Polishing & prophylaxis: manufacturers and brands

217 companies make or specify prophylaxis products among the 311 that list one with FDA, under 1,558 brand and model names. FDA has issued 96 510(k) clearances in this category, 0 of them in the last five years.

1976: 21977: 41978: 61979: 41980: 21981: 41982: 31984: 31985: 41986: 81987: 51988: 11989: 21990: 91991: 51992: 31993: 11994: 41995: 21997: 11999: 32000: 22003: 12004: 72006: 22007: 12010: 22011: 22012: 12014: 12017: 119801990200020102020

510(k) clearances per year, 1976–2026

Prophylaxis product manufacturers

Makers first, then the most recently active. “Maker” means the company manufactures the device or owns its specifications; a “lister” repacks, relabels, imports or distributes it.

CompanyCountryRoleBrands and models listedClearancesLatest
Dentsply Sirona, Inc.United StatesMakerNUPRO · NUPRO Sensodyne Prophylaxis Paste with NovaMin · Flex-View Interproximal Strips · Interproximal Serrated Strips1482026
Prismatik Dentalcraft, Inc.United StatesMakerBruxZir™ Adjustment & Polishing Kit · BruxZir™ Adjustment and Polishing Kit · BruxZir™ Blue Polishing Disc (3-pack) Refill · BruxZir™ Blue Polishing Disc, 3/Pk · +10562026
Mediclus Co., LtdSouth KoreaMakerDesens Bio-Care · DESENS BIO-CARE care kit · W-Gel Premium152026
Voco GmbHGermanyMakerClean Joy · Remin Pro · VOCO Paste · Dimanto · +21172026
Nakanishi, Inc.JapanMakerFLASH pearl · Perio Mate Powder372026
Shofu IncJapanMakerSUPER-SNAP · ACRYLIC KIT HP · ACRYLIC POLISHING KIT · ACRYLIC POLISHING KIT HP · +52962025
GC America Inc.United StatesMakerGC Tooth Mousse · GC Tooth Mousse Plus · MI Paste · MI Paste Plus · +71372026
Guilin Woodpecker Medical Instrument Co., Ltd.ChinaMakerProphylaxis Powder, Model: PT-S1, PT-S2, PT-S3122025
Sybron Dental SpecialtiesUnited StatesMakerComposite Surface Treatment · OptiDisc · Acrylic Adjustment Logic Set · AXIS Laminate Veneer Set · +852032026
Ultradent Products, Inc.United StatesMakerJIFFY CUPS · JIFFY DISKS · Jiffy HiShine Cups · Jiffy HiShine Disks · +16952026
Prevest Denpro LimitedIndiaMakerPlatina Hi-Gloss Composite Polishing Paste · Spectra Prophylaxis Paste72024
Ivoclar Vivadent, AGUnited StatesMakerOptraGloss · Politip · Proxyt · VD Polishing Paste942026
Kuraray Noritake Dental, Inc.JapanMakerNORITAKE DENTAL SUPPLY CO. LTD322025
Dent4You AGSwitzerlandMakerKENDA52026
Liaoning Upcera Co., LtdChinaMakerAbrasive material Pulverized Corundum · Polishing Paste102026
Deltamed GmbHGermanyMakerEnamelize™62024
Premier Dental Products CompanyUnited StatesMakerPremier Poli-Pro polishing System · Diamond Twist SCL™ · Diamond Twist SCO™ · Premier® 2pro® Disposable Prophy Angle · +4282026
Young Innovations IncUnited StatesMakerBRUSHES AND POLISHERS · DISPOSABLE PROPHYLAXIS CUPS · Prpphy Angles · Biotrol Prophylaxis Paste · +22232025
Kettenbach GmbH & Co. KGGermanyMakerProphyProtect142026
Sdi LimitedAustraliaMakerPolishing Paste82022
Guilin Kevin Peter Technology Co., Ltd.ChinaMakerTooth Whitening Gel32026
Guilin Refine Medical Instrument Co., LTD.ChinaMakerDental Prophylaxis Powder, Model: PT-X1, PT-X2, PT-X3, PT-X6, PT-X5, PT-X732026
Centrix, Inc.United StatesMakerProxiDiscs - Smooth · GripStrip Inter-Proximal Polisher442025
Vericom Co., Ltd.South KoreaMakerEAZI-BRUSH202026
Hager& Meisinger GmbHGermanyMakerMEISINGER Abrasives · MEISINGER Prophy Strips142025
Dentscare LtdaBrazilMakerDiamond · Diamond Flex · Diamond Pro · Diamond ACI & ACII · +4102024
Den-Mat Holdings, LLCUnited StatesMakerContours™ Coarse Anatomy Trimmers · D Fine™ Diamond Polishers For Hybrid Composites · D Fine Double Diamond™ Polishing System for Hybrid Composites and Porcelain · Porcelain Laminate Polishing Paste · +882026
Pac-Dent Inc.United StatesMakerAntiSplatr™ Disposable Prophy Angles · Promin Dental Desensitizing Gel · 341101 ProMin Tooth Desensitizing Paste Tube Kit, 25g/tube, 2 tubes/box, 10 box/case · 341102 ProMin F Tooth Desensitizing Paste with Fluoride Tube Kit, 25g/tube, 2 tubes/box, 10 box/case · +152022
Imicryl Dis Malzemeleri Sanayi VE Ticaret ASTürkiyeMakerROLENE · IMIPRINT, IMISHINE, IMIPOMZA, Panora 200, Royalry52022
Keystone IndustriesUnited StatesMakerBosworth Prophy Powder · Keystone Gelato Prophy Paste · Keystone Industries Prophy Cup · Prehma Prophylaxis Cups · +122025
Premium Plus (Dongguan) LimitedChinaMakerDisposable Prophy Brushes · Disposable Prophy Cups22025
Lakong Medical Devices Co., Ltd.ChinaMakerdisposable rubber cup · Prophylaxis, cups, brushes and angles · Polishing powder22026
HDI Inc.South KoreaMakerDenu Pumice Paste22022
Coltene/Whaledent AGSwitzerlandMakerAlpen Ceramic Plus ShapeGuard · Alpen Composite Plus ShapeGuard · Alpen Polishers · Alpen Zirconia Plus ShapeGuard · +54452022
Ortho Organizers, Inc.United StatesMakerGalaxy · Alpha-Pro · Alpha-Pro Kids Pack · Prophylaxis Paste82025
Tp Orthodontics, Inc.United StatesMakerMESIO-DISTAL REDUCER52022
Garrison Dental Solutions LLCUnited StatesMakerRally™ · eZr™32024
KaVo Dental GmbHGermanyMaker100.4672 - PROPHYflex 3 2018 black · 102342 - PROPHYpearls · 106.9926 - PROPHYflex 3 2018 violet · 106.9928 - PROPHYflex 3 2018 green · +1422021
GreenMark Biomedical Inc.United StatesMakerCrystLCare22025
Shenzhen Rogin Medical Co., Ltd.ChinaMakerPROPHY ANGLES · Polishing Disc/Polishing Strips/Polishing Cup/Polishing Brushes12025
Pacific Care LimitedHong Kong SAR ChinaMakerSunstar Butler, Inc.12025
Vigodent Industria e Comercio LtdaBrazilMakerMagic White · Magic White Office12025
Pulpdent CorporationUnited StatesMakerSparkle Diamond Polishing Paste1072021
Scientific PharmaceuticalsUnited StatesMakerDiamond Luster · FloroPhos · Glossy · Luster · +2732020
Reliance Orthodontic Products, Inc.United StatesMakerPREP STEP DISPOSABLE PROPHY ANGLE · Renew Finishing System Burs · Renew System Points · FIRST AND FINAL · +1322021
Cavex Holland BVNetherlandsMakerCavex Prophy Paste262015
S & C Polymer GmbHGermanyMaker—202009
Angelus Industria DE Produtos Odontologicos S/ABrazilMakerAngie Prophy112021
Hu-Friedy Mfg Co., LLCUnited StatesMakerHu-Friedy Mfg Co.,LLC · Pumice Cup · HuFriedyGroup · PWR Classic Powder · +182012
Whip Mix CorporationUnited StatesMakerPREPPIES FLOUR OF PUMICE82016
Medental Intl.United StatesMakerMedental Prophy Paste71999
Micerium S.P.A.ItalyMakerENA SHINY · Ena Oral Care Smart Prophy Brushes and Polishers · Ena Oral Care Smart Prophy Paste62011
Dxm Co., Ltd.South KoreaMakerDPA110 · Multiple names62020
Electro Medical Systems SAUnited StatesMakerAIR-FLOW CLASSIC Prophylaxis Powder; AIR-FLOW PERIO Prophylaxis Powder; AF SOFT Prophylaxis Powder; AF COMFORT; AF PERIO · AIR-FLOW MASTER PIEZON · AIR-FLOW PLUS Prophylaxis Powder; AIRFLOW PLUS52002
Rolence Ent., Inc.TaiwanMakerPROPHY ANGLE52009
Premium Plus International LimitedHong Kong SAR ChinaMakerDentmas · S-251 Prophy Cups, Screw-In · S-M252 Prophy Cups, RA, Metal Shank · T-251 Prophy Cups, Screw-In · +832017
Advanced Healthcare , Ltd.United KingdomMakerAHL Direct DIA (Diamond) Paste32003
Preventive Technologies, Inc.United StatesMakerPIVOT DISPOSABLE PROPHY ANGLE · MAXMIN Prophylaxis Paste · NADA Pumice Paste · NEXT Prophylaxis Paste32014
Integra LifeSciences CorporationUnited StatesMakerIntegra · Miltex · EvenWet · Lightning · +222014
Sunstar Americas, Inc.United StatesMakerBUTLER · DUROPRO · EEZ-TOUCH · MONSTERZ · +122013
Dental Technologies, Inc.United StatesMakerAlpha-Pro · Alpha-Pro Kids Pack · PROPHYLAXIS PASTE22013
Manufacturera Dental ContinentalMexicoMakerPolycril22001
Temrex Corp.United StatesMakerDIAMOND POLISHING PASTE · SATIN POLISHING PASTE22012
Microcopy, Div. Neo-Flo, Inc.United StatesMakerNeoShine · NeoDiamond IPR Strips · Gazelle · Minnow21989
World Bio Tech Co LtdSouth KoreaMakerAUTOMATIC STRIP, EASY STRIP, OTO STRIP22016
Dfl Industria E Comercio SABrazilMakerSteel Strips22013
Medical Products Laboratories, Inc.United StatesMakerEnamel Pro22004
Dental MorelliBrazilMaker—22014
Directa ABSwedenMakerProphyCare ProphyCup · ContacEZ Diamond Dental Strip · ContacEZ kits · ProphyCare12015
Dharma Research, Inc.United StatesMakerADS Prophylaxis Paste · Gelo-X Gel (Paste) · Qartz Prophylaxis Paste · Sherbet Prophylaxis Paste12015
COLTENE Holding AGSwitzerlandMakerAlpen Steel separating strips12003
Gebr. Brasseler GmbH & Co. KGGermanyMakerKOMET ABRASIVE DISK · KOMET ABRASIVE POINT · KOMET POLISHING STRIP12007
Abrasive Technology, Inc.United StatesMakerAPPLICATORS · MANDRELS · PRODIA · STAINBUSTER · +411990
Sawbros Industries Pvt., Ltd.IndiaMakerIPR Files · Separating · Separating Strips · Contouring Kit and Refill12017
E. C. Moore Company, Inc.United StatesMakerE.C. Moore; Cosmedenr · E.C. Moore · E.C. Moore; Cosmedent · PopWhite Prophy Paste11979
Medivance Instruments LimitedUnited KingdomMakerBAG 45S512003
Osung Mnd Co LtdSouth KoreaMakerSRTD15 · SRTD15H · SRTD25 · SRTD25H · +21——
TOR VM Ltd.RussiaMakerCat.#1.110 Mandrel for Stem Polishing Discs HP type · Cat.#1.111 Mandrel for Stem Polishing Discs RA type · Cat.#1.113 Mandrel for Stem Polishing Discs HP type · Cat.#1.115 Mandrel for Stem Polishing Discs RA type · +445——
Dentaurum GmbH & Co. KGGermanyMakerCorundum disc · Diasint Diamond disc · Disk Abrasive · Ultrasonic cleaning solution · +2——
Guilin Veirun Medical Technology Co., Ltd.ChinaMakerProphylaxis Powder (Model: Classic, UKC-S2, UKG-S3)——
Debo Medical Technology (Shijiazhuang) Co., Ltd.ChinaMakeralcohol lamp · CUP,PROPHYLAXIS · dental brush / prophylactic brush · dental cup · +10——
D.S.P. Industrial EIRELI EPPBrazilMakerDSP DIAMOND POLISHING · DSP POLISHING PASTE AL - ONE - TWO · DSP POLISHING PASTE AL - RESTORATION——
Prodont-HolligerFranceMakerArticle : PRODONT CUT OFF WHEEL AP3707011 · Article : PRODONT CUT OFF WHEEL AP3710011 · Article : PRODONT CUT OFF WHEEL AP3717011 · Article : PRODONT SPEEDY CUT OFF AP2206011 · +6——
Shenzhen Denco Medical Co LtdChinaMakerPROPHY ANGLES · Polishing Disc/Polishing Strips/Polishing Cup/Polishing——
TDV Dental LtdaBrazilMakerFinishing and Polishing Discs · Finishing and Polishing Discs Mandrel · PRAXIS · Praxis Mandrel · +41——
3R Industria e Comercio LtdaBrazilMakerDisk, Rubber Cup and Cone for Dentistry - Polishing and Finishing · Silicone Tips for Finishing and Polishing · MIR 1 · MIR 2 · +2——
Huanghua Promisee Dental Co., LtdChinaMakerPolishing Discs · Prophy brush · Prophy cup · Composite Polisher · +2——
Falcon Surgical Co. (Pvt.) Ltd.PakistanMakerDISK, ABRASIVE · CUP, PROPHYLAXIS——
B.J.M. Laboratories LtdIsraelMakerSTEP-1 PumEtch Resin Tooth Bonding Agent——
Polydentia S.A.SwitzerlandMakerAbrasive Polishing Strip · Tria-Shine——
Shanghai Alwings Medical Instrument Co.,Ltd.ChinaMakerPaper Cup · Plastic Cup · Prophy Angles · Prophy Brush · +6——
Shanghai Dochem Industries Co., Ltd.ChinaMakerCosmetic Discs · Prophy Brush · Prophy Cup · Dental burs · +3——
Shanghai Jolly Industrial Co., Ltd.ChinaMakerCup, prophylaxis · Prophy angle · Prophy brush, prophy cup · Polishing strips · +1——
Pascal InternationalUnited StatesMakerContra Angle · Prophy Angle · RADENT PROPHY PASTE · Radent Prophy Paste - Non Fluoride——
Dentatus ABSwedenMakerEVA Tips · LTA Lamineer Tips · Per-io-Tor Tips——
Shanghai Lions Industrial Co., Ltd.ChinaMakercup, prophylaxis · Prophy angle · Prophy brush, prophy cup · Polishing strips · +1——
Adolf Schweick Hardt GmbH & CoGermanyMakerCUP, PROPHYLAXIS——
Beyes Dental IncCanadaMakereasyProphy Disposable Angles and Cups——
Tangshan Zhengtong Exhibition Co., Ltd.ChinaMakerDisposable Prophy Angles, Disposable Prophy Cups · Prophy Angles, Prophy Cups · Prophy Brushes——
DFS-Diamon GmbHGermanyMaker———
NTI Kahla GmbH Rotary Dental InstrumentsGermanyMakerCeraGlaze · DiaGloss · Goldstar · NTI · +5——
ZOGEAR Medical Co., Ltd.ChinaMakerCUP, PROPHYLAXIS · POLISHING AGENT——
OSSTEM ORTHODONTICS Inc.South KoreaMaker650-08 Perforated Strip · 650-09 Reducer Strip(Thick) · 650-10 Reducer Strip(Thin) · 650-12 Reducer Strip(One-side)——
Solventum US LLCUnited StatesMaker———
Anqing Clean Dental Instrument Technology Co LtdChinaMakerdental polishing brush/ polishing kits · POINT, ABRASIVE · Polishing Kit IAC/WHEEL, POLISHING AGENT · AGENT, POLISHING, ABRASIVE, ORAL CAVITY——
Hubei Guarddent Medical Technology Co.,LtdChinaMakerProphy angle/cup/brush——
BH Medical Products Co., LtdChinaMakerProphy cup——
Cangzhou Lankang Medical Instruments Developing Co., Ltd.ChinaMakerDental polishing brush——
Jiangsu Yabaobao Medical Instrument Co.,Ltd.ChinaMakerDappen dish,glass,plastic Glass mortar & pestle Alcohol lamp No-stick mixing cup——
Bioclear Matrix Systems, LLCUnited StatesMakerMagic Mix Cups · Blasting Powder · Dual-Color Disclosing Solution · Magic Mix PrePolish——
READY SET IMPORT dba Mynt ProfessionalUnited StatesMakerRSI Prophy Angles——
TF New Material Sci and Tec Co.,ltdChinaMakerCup · Plastic Cup · Polish brush · Prophy angle——
Intensiv SASwitzerlandMakerIntensiv ApproxOpener · Intensiv Bevelshape · Intensiv Metal Diamond Strips · Intensiv Ortho-Strips · +15——
Produits Dentaires SASwitzerlandMakerDiamond Abrasive Strips · Odus Universal Strips · Steel Abrasive Strips · Transparent Strips——
Hefei Xingcheng Sanitary Products CO.,LTDChinaMakerDisposable Prophy Angle, Prophy cup, Prophy brush——
TeleflexUnited StatesMakerPILLING · PINEHOLE——
HuangHua DK Dental Co., LTD,ChinaMakerPolish wheel, strip, brush, cup, dish——
Onvet Medical Canada Inc.CanadaMakerSurePoli™ Polishing Disc System, SureFita™ IPR system · Glacier® Angles and Cups——
Everbrands, Inc.United StatesMakerDental Disk; Dental Rotary Instruments; Diamond Dental Rotary Instruments · ES-SMDISK-PRO-001 · ES-SMDISK-PRO-002 · ES-SMDISK-PRO-003 · +5——
Henan Baistra Medical Devices LimitedChinaMakerPOINT, ABRASIVE · Polishing Strip · WHEEL, POLISHING AGENT · AGENT, POLISHING, ABRASIVE, ORAL CAVITY——
Henan Lusterdent Medical Instrument Co.,LtdChinaMakerProphy Brushes and Cups · Abrasive Diamond Strips——
MDT Micro Diamond Technologies LtdIsraelMakerDental Disc · Dental Rotary Instruments · Diamond Dental Rotary Instruments · Daisy · +4——
Onuge Personal Care(Guangdong)Manufacturer Group Co., LTD.ChinaMakerBocaBella Natural Teeth Whitening Strips · BocaBella Teeth Whitening U-wraps · Charcoal Teeth Whitening Strips · CVSHealth Brilliant White Whitening Strips(Coconut flavor) · +6——
Aadi Med Private LimitedIndiaMakerPro-Paste · Pumice powder (Different Grits) · Saphire (Diamond Polishing Paste) · Zirprophy——
Hangzhou Wise Medical Device Co.,LtdChinaMakerPolishing Strip——
Maquira Industria de Produtos OdontologicosBrazilMakerAIRON POLYESTER ABRASIVE STRIPS · AIRON STEEL ABRASIVE STRIP · AIRON BICARBONATE · DIAMOND UNIVERSAL——
CDM Center of Excellence Ltd.ChinaMakerCup, Prophylaxis · Agent, Polishing, Abrasive, Oral Cavity——
Gavin Biotechnology Co.,ltdChinaMakerUtrasonic Tips ( for EMS/SATALEC/WOODPECKER/KAVO/SIRONA) · Dental Polishing Machine · Dental Loupe · Surgical magnifying glass——
LLRN Personal Care (Shenzhen) Co.,ltdChinaMakerTeeth whitening kit, Teeth Whitening Strips——
Zhejiang Yamei Medical Equipment Technology Co., Ltd.ChinaMakerProphy Cup Brush · Prophy Paste——
Boen Healthcare Co LtdChinaMakerProphylaxis Cup; Prophy Cup——
Erskine DentalAustraliaMakerSuperdaps, Plastic Dappen Dish, Mixing Well, Brush Holder——
Viarden Lab LLCUnited StatesMakerPROPHY PASTE VIARDEN LAB, DENT GLOSS, VIARGLOSS——
Xiantao S&J Protective Products Co., LtdChinaMakerProphy Cup; Prophy Brush; Prophy Angles, Dappen Dishes——
Hefei Mlush Sanitary Products Co., LtdChinaMakerpolish brush/cup/ prophy angle——
Dongguan Wanjin Industrial Co., LtdChinaMakerCUP——
Hager & WerkenGermanyMakerCOMPO BLITZ——
Shenzhen Jie Bishi Technology Co., LTDChinaMakerP1,P2,P3,P4,P5,P6,P7,P8,P9,P10,P11,P12,P13,P14,P15,P16,P17,P18,P19,P20——
Jordco IncUnited StatesMakerPure Buff: Acrylic Polishing Kit · Pure Buff: Acrylic Polishing Wheels (refill pack)——
Ashtel Studios, Inc.United StatesMakerTeeth whitening strips——
Guangzhou Four E's Scientific Co., Ltd.ChinaMakerProphylaxis Cup——
BUSCH & CO. GmbH & Co. KGGermanyMakerABRASIVE DEVICE AND ACCESSORIES · UNMOUNTED WHEELS · ABRASIVE DEVICE AND ACESSORIES · MOUNTED POINTS——
Changsha Easyinsmile Intelligence Technology Co.,Ltd.ChinaMakerDental Strip · Photosensitizer Models: High, Medium, Low——
EMS Electro Medical Systems SASwitzerlandMakerAIR-FLOW POWDER · AIRFLOW PLUS POWDER——
Nawaz and SonsPakistanMakerEHK / CUP, PROPHYLAXIS——
Wellmed Dental Medical Supply Co., Ltd.ChinaMakerCUP, PROPHYLAXIS——
Cordica Medical (Formally Team Technologies, Inc)United StatesMaker———
Guangxi Ehall Medical Technology Co.,LtdChinaMakerProphy cup, Nylon Prophy Brush, Prophy Angle, Proply Motor X1——
Jiangsu Province Yangzhou Shuguang Toothbrush ManuChinaMakerProphy Brush——
SKY DENT Corp for dental tradingUnited StatesMakerSKY DENT PROPHY PASTE CUPS - 1DERFUL PROPHY PASTE CUPS——
Zhejiang Mediunion Healthcare Group Co LtdChinaMakerdental cup——
ASA DentalItalyMakerDAPPEN DISHES——
Edenta EtablissementLiechtensteinMakerCERAGLAZE · DIAGLOSS AND PDQ · NTI · POLISHERS——
Yongqing Huaguan Dental Instruments FactoryChinaMakerdental mixing well——
Garnet DentechSouth KoreaMakerDental Orthodontic Strip——
Hefei Jingcheng Plastic Products Co. LtdChinaMakerDisposable Prophy Angles——
PHS Do Brasil LTDABrazilMakerPOTENZA FINEX CUT · POTENZA FINEX DISC · POTENZA FINEX MANDREL · POTENZA ABRASIONE · +4——
Shenzhen Mold and Manufacturing Co LtdChinaMakerBeaming White——
Anhui JM Healthcare Products Co.,Ltd.ChinaMakerCUP, PROPHYLAXIS,Prophy Cup Brush,prophy angle——
Bio-Art Equipamentos Odontologicos LtdaBrazilMakerMicroblaster Standard——
Creative China Creations LtdHong Kong SAR ChinaMakerPolishing Wheel——
Dhef Inc.TaiwanMakerCUP · PROPHYLAXIS——
Peter Brasseler Holdings, LLCUnited StatesMakerVersaFlex Strip——
Shanghai Toboom Dental Techology CO., LTD.ChinaMakerDISK, ABRASIVE · POINT, ABRASIVE · WHEEL, POLISHING AGENT——
Weihai Jieshi Commodity Manufacture Co., Ltd.ChinaMakerDental whitening strip——
Chung Song Industrial Co.South KoreaMakerABRASIVE STONE POINT——
ConamcoUnited StatesMakerMedental Prophy Paste——
Diaswiss, S. A.SwitzerlandMakerDISK, ABRASIVE · POINT, ABRASIVE · WHEEL, POLISHING AGENT——
Prisman GmbHGermanyMakerProphypowder FRESH · Prophypowder FRESH - Mint · Prophypowder PERIO PLUS · Prophypowder PERIO PLUS - Mint · +4——
Yueying Medical Instruments (Langfang) Co., Ltd.ChinaMakerDental Mixing Well——
Anhui Ares Medical Technology Co.,Ltd.ChinaMakerprophy angle——
Changzhou Shengkang Medical Instrument Co.,LTDChinaMakerPolishing brush——
Dedeco International, Inc.United StatesMakerDisk Abrasive · Point Abrasive · Agent, Polishing, Abrasive, Oral Cavity——
Indusbello Ind. e Com. de Prod. Med. e Odont. Ltda.BrazilMakerINDUSBELLO——
Dongguan Yilong Medical Supplies Co., Ltd.ChinaMakerProphy Angle, Prophy Brush, Prophy Cup——
Jota AGSwitzerlandMakerJOTA——
Prima Dental GroupUnited KingdomMakerPolisher, Dental · Prima Dental Illume——
Hangzhou Rollmed Co.,Ltd.ChinaMakerSTRIP CAP——
Zentro Enterprise Pvt. Ltd.IndiaMakerDISK, ABRASIVE——
Chi Feng Co.,ltdTaiwanMakerSand Trap——
Dongguan Ouwen Medical Device Technology Co., Ltd.ChinaMakerProphy Cup; Prophy Brush——
Hopf Ringleb & Co GmbH & CieGermanyMakerHORICO——
Josef Ganter Feinmechanik GmbHGermanyMakerDisk, Abrasive · MANDRELS FOR VARIOUS TYPES OF——
Shenzhen Soga Technology Co. Ltd.ChinaMakerAIR-FLY——
VH Technologies LtdUnited StatesMakerDavid Hornbrook · DiaShine · Lucida——
Weihai Xingtai Packaging Products Co., Ltd.ChinaMakerProphy angle——
Nomax Inc.United StatesMakerPRO CARE PROPHYLAXIS PASTE MIX——
Reco-Dent International Co., Ltd.TaiwanMakerAbrasive Disk · Prophylaxis Cup——
Shenzhen Yuechi Innovation Technology Co.,LtdChinaMakerOCJOY Solid Toothpaste (Powder Form) (200 g/bottle) · OCJOY Solid Toothpaste (Powder Form) (30 g/bottle)——
Dell Dent Ltd.IsraelMakerAIRBRUSH——
Dome Inc.United StatesMakerDome abrasive——
Foshan Fengyun Medical Technology Co., Ltd.ChinaMakerDental Polishing Bur——
Huizhou Hizorion Tech Co.,LtdChinaMakerBW-HW-CP · Mug or Cup.---BW-HW-MG,Sl.-HW-MG,ST-HW-MG——
Jiangsu JianYu Health Medical Co., LtdChinaMakerProphylaxis Cup——
Liaoning Xinaite Technology Co.,LtdChinaMakerPolishing Paste——
Ningbo Xinwell Medical Technology Co., Ltd.ChinaMakerAll Ceramic Polishers · FlexiPoints · MASS SPECTROMETRY MONITORING LINE CONONECTORS——
Fischer Surgical Inc.United StatesMakerDISK, ABRASIVE——
Jung Chen Technology Co., LtdChinaMakerDisposable Prophy Angle——
Cole InstrumentsUnited StatesMakerRing Cup 2-pocket——
Dr Hopf GmbH and Co KGGermanyMakerSUNSHINE DIAMONDS——
Dr. Wittmann GmbH & Co. KGGermanyMakerAirflow Classic, Airflow Perio, Airflow Plus——
Eve Ernst Vetter GmbHGermanyMakerEVE——
guangdong fuqiang beauty equipment co.,LimitedChinaMakerMetal polishing machine——
Guangzhou FuZelong Hygiene Material Co LtdChinaMakerPUYUAN——
SUN Oberflaechentechnik GmbHGermanyMakerPolisher for dental use——
Zonefly Medical Devices Co., Ltd.ChinaMakerWHEEL, POLISHING AGENT——
BBC Cellpack Technology AGSwitzerlandMaker———
Dentex Dental Industrial CorpTaiwanMaker———
Helmut Zepf Medizintechnik GmbHGermanyMaker———
Oogie Solutions LLCUnited StatesMaker———
Proguard Health Inc.United StatesMaker———
Samson Innovation Corp. Ltd.Hong Kong SAR ChinaMaker———
Span Packaging Services LLC dba Multi-Pack SolutionsUnited StatesMaker———
Spectrum Plastics GroupUnited StatesMaker———
Stoddard MFG. Co., Ltd.United KingdomMaker———
Track of SurgicalPakistanMaker———
TVP Developments LtdHong Kong SAR ChinaMaker———
Zest Anchors, LLCUnited StatesManufacturer—262026
Kulzer, LLCUnited StatesContract manufacturerVenus Supra372026
Parkell, IncUnited StatesContract manufacturer—582025
Cosmedent, Inc.United StatesRepacker / relabelerEnamelize · Porcelize · FlexiDisc · FlexiWheel · +6272024
Lares ResearchUnited StatesManufacturerPastel Prophy Paste, Mint, Coarse Grit82022
Vita Zahnfabrik H. Rauter GmbH & Co. Kg.GermanyManufacturerVITA ENAMIC Polishing Set VITA SUPRINITY® Polishers82026
W&H Dentalwerk Buermoos GmbHAustriaContract manufacturer—172026
Amann Girrbach AGAustriaForeign exporter—32026
DSI Dental Solutions LtdIsraelManufacturerDSI Prophylaxis Paste · Pumice Paste22025
Bicon, LLCUnited StatesManufacturerPolishing Kit IAC182015
Dent Zar, Inc.United StatesRepacker / relabelerPolishers121996
Buffalo Dental Mfg. Co., Inc.United StatesManufacturerABRASIVES111996
ITENA ClinicalFrancePrivate-label distributorDISK, ABRASIVE · POINT, ABRASIVE · WHEEL, POLISHING AGENT82017
CNC Manufacturing, Inc.United StatesManufacturer—52007
DentamericaUnited StatesRepacker / relabelerDENTAMERICA42010
Dentatus USA Ltd.United StatesRepacker / relabelerLTA/EVA tips42004
Tpc Advanced Technology, Inc.United StatesRepacker / relabelerTPC Disposable Prophy Cup32007
Hager Worldwide, Inc.United StatesManufacturerHager Prophy Angles · Hager Prophy Brushes · Rotoprox · Almore Aluminum Oxide · +122005
George Taub Products & Fusion Co., Inc.United StatesManufacturer—21986
DB Orthodontics LimitedUnited KingdomForeign exporterAiro Interdental Strips22010
DMG America, L.L.C.United StatesContract manufacturerAgent, Polishing, Abrasive, Oral Cavity - Kolorz12013
Ziacom Medical, S.L.SpainForeign exporterJOTA12019
SS White Burs LLCUnited StatesManufacturerJazz Polisher · Strip, Polishing Agent - Jazz Finishing Strip12008
Sotera Health LLCUnited StatesContract manufacturer———
One DashcorpUnited StatesRepacker / relabelerValdent USA RA Mandrel, Contra-Angle · Valdent USA Disposable Prophy Cups, Latch Type, 4 Leaves, White, Soft Silicone · Valdent USA Disposable Prophy Cups, Latch Type, 6 Leaves, White, Soft Silicone · Valdent USA Prophy Brush, Latch Type, White——
Wuxi Lyusmile Imp and Exp Co.,ltdChinaPrivate-label distributordental prophy brush · DISPOSABLE PROPHY BRUSH · POLISHING BRUSH · prophy angle · +7——
Jersey Dental SuppliesUnited StatesRepacker / relabelerGC MI PASTE PLUS · MI PASTE · NUPRO PROPHY PASTE · ACRYPOINT; BROWNIE; BURBUTLER ALL CERAMIC ABRASIVE KIT; BURBUTLER CADMASTER KIT; CERAMASTER; CERAMISTE; CERAMISTE SOFT;——
Dentimed Sao Joao LLCUnited StatesRepacker / relabelerTORINO · Angelus——
TitanLinks Logistics LLCUnited StatesRepacker / relabelerPolishing · Disposable Prophy Angle · Finishing & Polishing · Dental Instrument · +1——
Jmu Dental, Inc.United StatesRepacker / relabelerProphy Angles; Prophy Brushes; Prophy Cups; Disposable Prophy Angles; Disposable Prophy Cups · Micro blaster Standard (Midwest) · EHM - STRIP, POLISHING AGENT——
Patterson Companies, Inc.United StatesForeign exporterPatterson Abrasive Disk · Patterson Prophy Cups · Patterson Polishing Agent · AGENT, POLISHING, ABRASIVE, ORAL CAVITY——
Soher Med LimitedHong Kong SAR ChinaForeign exporterdental · Cup · abrasive · Polishing——
STERIS CorporationUnited StatesContract sterilizerWhiteBurr3283 (WP, CH1) - Jazz Polisher · Medivance9720 (RG) - BAG 45S5——
HSG-S CorpUnited StatesManufacturer———
Aspen Surgical ProductsUnited StatesContract manufacturerSymmetry Surgical——
Samtrade Supplies Inc.CanadaForeign exporterSoflex / Enhance polishing · Nupro Paste——
Summit Orthodontic Services, Inc.United StatesRepacker / relabelerECONO CUTTER · Scotchbrite abrasive wheels · Abrasive Points · Polishing Points · +2——
International Orthodontics Services. PCUnited StatesRepacker / relabelerDiamond Disc 3/4 and 7/8 · Abrasive Strip single / double fine and medium——
Premium Plus DentalUnited StatesListerDISK ABRASIVE · Densco Prophy Cups,Brushes · Premium Plus Prophy Cups · House Brand Point Abrasive · +1——
SPS/Crosstex InternationalUnited StatesManufacturerProphy Paste · Sparkle™ FREE Prophy Paste with Xylitol · Sparkle™ Prophy Paste with Xylitol——
Csy International LLCUnited StatesRepacker / relabelerJ&J ORTHODONTICS——
GoldenDentUnited StatesRepacker / relabelerPT-S1, PT-S3 / SANDBLASTING POWDER——
Yizur LtdHong Kong SAR ChinaForeign exporterFinishing Material · Prophy Angle · Finishing & Polishing · WHEEL, POLISHING AGENT——
CARGUS International Inc.United StatesRepacker / relabelerMARK3® White Stones · MARK3® Enamel Care Prophy Paste · MARK3® Prophy Paste——
LLD Care d.o.o.CroatiaForeign exporterGlitter, Paste Cups · Enamel, Prophy Paste——
AMD Medicom IncCanadaForeign exporterMedicom Denticare Pro-Polish——
Unisource Shanghai Ltd.ChinaForeign exporterTeeth Whitening Strips——
First Dental Supplies LLCUnited StatesRepacker / relabelerPOINT, ABRASIVE · STRIP, POLISHING AGENT——
Maxill Inc.United StatesForeign exporterMaxill——
Shanghai MU PROMOTIONS Co., Ltd.ChinaForeign exporterDappen Dish,Glass,Plastic Glass Mortar & Pestle Alcohol Lamp No-Stick Mixing Cup——
Beaming White LLCUnited StatesManufacturerBeaming White——
Ortho Solutions LCUnited StatesContract manufacturer———
Shanghai smedent medical instrument co., ltd.ChinaForeign exporterprophy angle ,prophy brush, prophy cup, prophy point——
Meta Dental Corp.United StatesRepacker / relabelerABRASIVE STONE POINT——
Esthetic Orthodontic Company of America LLCUnited StatesRepacker / relabelerIPR Handsaws——
Bina LimitedBelizeForeign exporterABRASIVE——
ATOMO Dental, Inc.United StatesRepacker / relabelerProphy Angles; Prophy Brushes; Prophy Cups; Disposable Prophy Angles; Disposable Prophy Cups——
Dental Brands for LessCanadaForeign exporterDENTSPLY——
Dukal CorporationUnited StatesSpecification developerUnipack Prophy Angles——
Dentonics IncUnited StatesRepacker / relabelerMaster-Dent——
Shenzhen Upcera Digital Dental Technology Co., LtdChinaForeign exporterAbrasive material Pulverized Corundum; Polishing Paste——
W&H Impex Inc.CanadaForeign exporter———
Axiodent Inc.United StatesRepacker / relabelerAxioGloss · AxioShine Fresh Fruit · AxioShine Fresh Mint · AxioShine Fresh Orange · +2——
Signa Medical, Inc.United StatesRepacker / relabelerDenmat Ceri-Sander——
HI Medical Co., Ltd.South KoreaForeign exporterDentsply——
Sanicure BVNetherlandsForeign exporter———
Zapalign LLCUnited StatesRepacker / relabeler———
O&S Dental IncUnited StatesManufacturer for export———
Oriental International Supplies LimitedHong Kong SAR ChinaForeign exporterProphy Brush——
Double White Medical Technology Development(Guangzhou) Co. LChinaForeign exporterCharcoal Teeth Whitening Strips; CVSHealth Brilliant White Whitening Strips(Coconut flavor) · CVSHealth Brilliant White Whitening Strips(Peach flavor); Dissolving Teeth Whitening Strips · Fitreno Teeth Whitening Strips-ONG-YT-01; Teeth Whitening Dry Strips · Teeth Whitening Gel Strips; Teeth Whitening Strips,Teeth Whitening U-wraps——
Guangzhou White Pro Oral Care Products Co., Ltd.ChinaForeign exporterCharcoal Teeth Whitening Strips; CVSHealth Brilliant White Whitening Strips(Coconut flavor) · CVSHealth Brilliant White Whitening Strips(Peach flavor); Dissolving Teeth Whitening Strips · Fitreno Teeth Whitening Strips-ONG-YT-01; Teeth Whitening Dry Strips · Teeth Whitening Gel Strips; Teeth Whitening Strips,Teeth Whitening U-wraps——
Prais Reliable Dental Supplies S.ASeychellesForeign exporter———
Maverick Dental, LLCUnited StatesRepacker / relabelerEraseZir · Re-Glaze——
HEXA DentalUnited StatesContract manufacturer———
ACURATA GMBH & CO. KGaAGermanyManufacturerAcurata——
CWGC LA Inc.United StatesRepacker / relabelerDrinking Paper Cup, 3 oz., White Color 100 cups/bag, 50 bags/CS = 5,000 cups/case (Model AMC3 PA) · Drinking Paper Cup, 7 oz., White Color 100 cups/bag, 20 bags/CS = 2,000 cups/case (Model AMC7 PA) · Paper Portion Container, 3.5 oz, White Color 100 cups/bag, 50 bags/CS = 5,000 cups/case (Model AMC3 5PA) · Plastic Cup, 1 oz., Transparency Color, 100 cups/bag, 50 bags/CS = 5,000 cups/case (Model AMC1 PL)——
Opa Dental, LLCUnited StatesRepacker / relabelerCeramic grinder · Rubber polisher · Silicone polisher——
Kash Sales Inc.CanadaForeign exporter———
New Pentastar Medical Products Co. LimitedHong Kong SAR ChinaForeign exporterDental cup, Denture Cup——
Olulo LLCUnited StatesRepacker / relabeler———
PacStar International, inc.United StatesRepacker / relabelerAngle cup——
Rece International Corp.United StatesRepacker / relabelerVIAMED PROPHYLAXIS(DENTAL)CUP——
Strauss & Co.IsraelManufacturerStrauss & Co. Polishers——
3D Dental Designs and Development LLCUnited StatesContract manufacturer———
Bright Supply IncUnited StatesLister———
AD Supply Group LimitedUnited KingdomForeign exporter———
Dylan Lucas International IncCanadaForeign exporter———
Mainline Medical Dental SupplyCanadaForeign exporter———
MHM Grupo Diamante, S.A. de C.V.MexicoForeign exporter———
Oketz Logistics LLCUnited StatesRepacker / relabeler———
Pharmco Medical B.V.NetherlandsForeign exporter———
Tas Medical SupplyUnited StatesForeign exporter———
Worldwide Supplies LimitedHong Kong SAR ChinaForeign exporter———
Zircon Plus LimitedIsraelForeign exporter———

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

Where prophylaxis products are made

Number of makers in this category with a manufacturing establishment in the country.

FDA device types in this category

Device typeClassRegulationMakersClearances
Oral Cavity Abrasive Polishing AgentEJR1872.60309577
Prophylaxis CupEHK1872.6290758
Polishing Agent StripEHM1872.6010522
Abrasive DiskEHJ1872.6010464
Abrasive PointEHL1872.6010414
Polishing Agent WheelEJQ1872.6010371

Recent clearances

Decided510(k)DeviceApplicantDevice type
11 Sep 2017K171189AIR-FLOW PLUS Prophylaxis powderE.M.S Electro Medical Systems S.AEJR Oral Cavity Abrasive Polishing Agent
26 Mar 2014K131760WHIP MIX PREPPIES PLUSWhip Mix CorporationEJR Oral Cavity Abrasive Polishing Agent
6 Aug 2012K121698NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMINDentsply International, Inc.EJR Oral Cavity Abrasive Polishing Agent
14 Mar 2011K103114OSSPRAY SYLC CROsspray, Ltd.EJR Oral Cavity Abrasive Polishing Agent
3 Feb 2011K102053BUTLER CALCI-FLOR PROPHYLAXIS PASTESunstar Americas, Inc.EJR Oral Cavity Abrasive Polishing Agent
21 Oct 2010K101104REMIN PROVoco GmbHEJR Oral Cavity Abrasive Polishing Agent
17 Jun 2010K100539PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDEPreventive Technologies, Inc.EJR Oral Cavity Abrasive Polishing Agent
12 Apr 2007K070854GC MI PASTE PLUSGC America Inc.EJR Oral Cavity Abrasive Polishing Agent
15 Dec 2006K062502OSSPRAY CLEANING COMPOUNDOspray, Ltd.EJR Oral Cavity Abrasive Polishing Agent
21 Nov 2006K062166ENAMEL PROPremier Dental Products CompanyEJR Oral Cavity Abrasive Polishing Agent
26 Oct 2004K042048GELATO PROPHYLAXIS PASTEDeepak Products, Inc.EJR Oral Cavity Abrasive Polishing Agent
20 Oct 2004K042200MI PASTEGC America Inc.EJR Oral Cavity Abrasive Polishing Agent
23 Aug 2004K041371BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMINNovamin Technology, Inc.EJR Oral Cavity Abrasive Polishing Agent
7 Jul 2004K040988ZIRCON-F PROPHYLAXIS PASTEPascal Co., Inc.EJR Oral Cavity Abrasive Polishing Agent
18 Jun 2004K033785PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDEPhilips Medical Systems International BVEJR Oral Cavity Abrasive Polishing Agent
9 Jun 2004K040661RADENT PROPHY PASTEPascal Co., Inc.EJR Oral Cavity Abrasive Polishing Agent
7 Jan 2004K033449PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICESProfessional Dental Technologies Therapeutics, Inc.EJR Oral Cavity Abrasive Polishing Agent
11 Jul 2003K024343BUTLER GUM PROPHY PASTE WITH NOVAMINUsbiomaterials Corp.EJR Oral Cavity Abrasive Polishing Agent
14 Dec 2000K002989PROCLUDEOrtek Therapeutics, Inc.EJR Oral Cavity Abrasive Polishing Agent
24 Mar 2000K000169NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSANDentsply Intl., Inc.EJR Oral Cavity Abrasive Polishing Agent
13 May 1999K9904823M CLINPRO PROPHY PASTE, MODEL 12611Minnesota Mining and Mfg. Co.EJR Oral Cavity Abrasive Polishing Agent
9 Feb 1999K973289RE NUPacific Rim Dental, Inc.EJR Oral Cavity Abrasive Polishing Agent
29 Jan 1999K983966NUPRO PROPHYLAXIS PASTE WITH FLOURIDE AND TRICLOSANDentsply Intl., Inc.EJR Oral Cavity Abrasive Polishing Agent
31 Mar 1997K962370PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDEChallenge Products, Inc.EJR Oral Cavity Abrasive Polishing Agent
29 Sep 1995K953628PROPHY ANGLERolence Enterprise, Inc.EHK Prophylaxis Cup
2 May 1995K951016DISPOSABLE PROPHYLAXIS ANGLEPreventive Technologies, Inc.EHK Prophylaxis Cup
15 Dec 1994K944575AQUAFRESH PLAQUE FIGHTING GUMSmithkline Beecham Consumer Healthcare ProductsEJR Oral Cavity Abrasive Polishing Agent
4 Nov 1994K942851SMILE INTEGRATED PROPHYLAXIS PASTE RINGSGermiphene Corp.EJR Oral Cavity Abrasive Polishing Agent
19 Apr 1994K940496PROPHY PASTEChallenge Products, Inc.EJR Oral Cavity Abrasive Polishing Agent
26 Jan 1994K935925VISION PROPHY PASTE WITH FLUORIDEBlock Drug Company, Inc.EJR Oral Cavity Abrasive Polishing Agent
16 Nov 1993K933893VISION PROPHY PASTE WITHOUT FLUORIDEBlock Drug Company, Inc.EJR Oral Cavity Abrasive Polishing Agent
5 Nov 1992K923675DENSPRO MEDIUM MINT PROPHY PASTETeledyne GetzEJR Oral Cavity Abrasive Polishing Agent
5 Nov 1992K923674DENSPRO COARSE MINT PROPHY PASTETeledyne GetzEJR Oral Cavity Abrasive Polishing Agent
9 Sep 1992K923020CLEANICHawe Neos DentalEJR Oral Cavity Abrasive Polishing Agent
19 Nov 1991K911111MICROMILLS, PATRIOTS, ALPHA GOLD DIAMONDSVermont Diamond InstrumentsEHJ Abrasive Disk
16 Sep 1991K912945SATIN PROPHYLAXIS PASTEDentsply Intl., Inc.EJR Oral Cavity Abrasive Polishing Agent
10 Jun 1991K905303ABUTMENT GLOImplant Innovations International, Inc.EJR Oral Cavity Abrasive Polishing Agent
30 May 1991K911284PULPDENT DIAMOND POLISHPulpdent CorporationEJR Oral Cavity Abrasive Polishing Agent
28 Mar 1991K903986SWIRL PROPHYLAXIS PASTEBio-Medica ConceptsEJR Oral Cavity Abrasive Polishing Agent
5 Dec 1990K904199HORIZON REGULAR ETCHING GELHorizon Chemical Co.EJR Oral Cavity Abrasive Polishing Agent