Miscellaneous devices · 21 CFR 872 Subpart G

Oral Cavity Abrasive Polishing Agent

FDA device type “Agent, Polishing, Abrasive, Oral Cavity”.

FDA codeEJRClass121 CFR872.6030Pathway510(k) exemptCategoryPolishing & prophylaxis
Companies listing it
13395 makers
Brands and models
267
510(k) clearances
770 in five years
FDA name
Agent, Polishing, Abrasive, Oral Cavity
1976: 21977: 21978: 11979: 11980: 11981: 31982: 21984: 31985: 41986: 71987: 41988: 11989: 21990: 81991: 41992: 31993: 11994: 41997: 11999: 32000: 22003: 12004: 72006: 22007: 12010: 22011: 22012: 12014: 12017: 119801990200020102020

510(k) clearances per year, 1976–2026

Companies that list EJR

133 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Dentsply Sirona, Inc.United StatesMakerNUPRO · NUPRO Sensodyne Prophylaxis Paste with NovaMin1482026
Mediclus Co., LtdSouth KoreaMakerDesens Bio-Care · DESENS BIO-CARE care kit · W-Gel Premium152026
Voco GmbHGermanyMakerClean Joy · Remin Pro · VOCO Paste1172026
Nakanishi, Inc.JapanMakerFLASH pearl · Perio Mate Powder372026
Shofu IncJapanMakerCOMPOSITE PASTE · COMPOSITE PASTE GERMANY · COMPOSITE POLISHING PASTE · DIRECT DIA POLISHING PASTE · +2962025
GC America Inc.United StatesMakerGC Tooth Mousse · GC Tooth Mousse Plus · MI Paste · MI Paste Plus · +11372026
Guilin Woodpecker Medical Instrument Co., Ltd.ChinaMakerProphylaxis Powder, Model: PT-S1, PT-S2, PT-S3122025
Sybron Dental SpecialtiesUnited StatesMakerCleanic · Cleanpolish · Clinpro · Hawe Paste for Implants · +42032026
Ultradent Products, Inc.United StatesMakerOPALUSTRE · Ultrapro Tx Prophy Paste952026
Prevest Denpro LimitedIndiaMakerPlatina Hi-Gloss Composite Polishing Paste · Spectra Prophylaxis Paste72024
Ivoclar Vivadent, AGUnited StatesMakerProxyt · VD Polishing Paste942026
Liaoning Upcera Co., LtdChinaMakerAbrasive material Pulverized Corundum · Polishing Paste102026
Deltamed GmbHGermanyMakerEnamelize™62024
Premier Dental Products CompanyUnited StatesMakerDiamond Paste · Enamel Pro Prophy Paste282026
Young Innovations IncUnited StatesMakerBiotrol Prophylaxis Paste · Denticator Prophylaxis Paste · FIRST CHOICE PROPHY COARSE CHERRY 67PK · FIRST CHOICE PROPHY COARSE MINT 67PK · +17232025
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
Dentscare LtdaBrazilMakerDiamond ACI & ACII · Diamond Excel · Diamond Excel Ultrafine · Diamond Master · +1102024
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 Paste82026
Pac-Dent Inc.United StatesMakerPromin 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 · 341103 ProMin F Tooth Desensitizing Paste with Fluoride Pen, 4.5 ml52022
Imicryl Dis Malzemeleri Sanayi VE Ticaret ASTürkiyeMakerIMIPRINT, IMISHINE, IMIPOMZA, Panora 200, Royalry52022
Keystone IndustriesUnited StatesMakerBosworth Prophy Powder · Keystone Gelato Prophy Paste22025
Lakong Medical Devices Co., Ltd.ChinaMakerPolishing powder22026
HDI Inc.South KoreaMakerDenu Pumice Paste22022
Coltene/Whaledent AGSwitzerlandMakerBiosonic Suvi Air Polishing Powder · Jiffy Cups · Jiffy Disks · Jiffy HiShine Cups · +6452022
Ortho Organizers, Inc.United StatesMakerAlpha-Pro · Alpha-Pro Kids Pack · Prophylaxis Paste82025
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
Vigodent Industria e Comercio LtdaBrazilMakerMagic White · Magic White Office12025
Pulpdent CorporationUnited StatesMakerSparkle Diamond Polishing Paste1072021
Scientific PharmaceuticalsUnited StatesMakerDiamond Luster · FloroPhos · Glossy · Luster · +2732020
Cavex Holland BVNetherlandsMakerCavex Prophy Paste262015
S & C Polymer GmbHGermanyMaker—202009
Whip Mix CorporationUnited StatesMakerPREPPIES FLOUR OF PUMICE82016
Medental Intl.United StatesMakerMedental Prophy Paste71999
Micerium S.P.A.ItalyMakerEna Oral Care Smart Prophy Paste · ENA SHINY62011
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
Premium Plus International LimitedHong Kong SAR ChinaMakerProphy Paste Cup Medium, Fine and Cup Holder32017
Advanced Healthcare , Ltd.United KingdomMakerAHL Direct DIA (Diamond) Paste32003
Preventive Technologies, Inc.United StatesMakerMAXMIN Prophylaxis Paste · NADA Pumice Paste · NEXT Prophylaxis Paste32014
Integra LifeSciences CorporationUnited StatesMakerMiltex22014
Dental Technologies, Inc.United StatesMakerAlpha-Pro · Alpha-Pro Kids Pack · PROPHYLAXIS PASTE22013
Manufacturera Dental ContinentalMexicoMakerPolycril22001
Temrex Corp.United StatesMakerDIAMOND POLISHING PASTE · SATIN POLISHING PASTE22012
Medical Products Laboratories, Inc.United StatesMakerEnamel Pro22004
Directa ABSwedenMakerProphyCare12015
Dharma Research, Inc.United StatesMakerADS Prophylaxis Paste · Gelo-X Gel (Paste) · Qartz Prophylaxis Paste · Sherbet Prophylaxis Paste12015
Abrasive Technology, Inc.United StatesMakerLUMINESCENCE · LUMINESCENCE PLUS11990
Sawbros Industries Pvt., Ltd.IndiaMakerContouring Kit and Refill12017
E. C. Moore Company, Inc.United StatesMakerPopWhite Prophy Paste11979
Medivance Instruments LimitedUnited KingdomMakerBAG 45S512003
Guilin Veirun Medical Technology Co., Ltd.ChinaMakerProphylaxis Powder (Model: Classic, UKC-S2, UKG-S3)——
Debo Medical Technology (Shijiazhuang) Co., Ltd.ChinaMakerdental abrasive · dental polishing paste · Prophy paste,Polishing Paste——
D.S.P. Industrial EIRELI EPPBrazilMakerDSP DIAMOND POLISHING · DSP POLISHING PASTE AL - ONE - TWO · DSP POLISHING PASTE AL - RESTORATION——
Shenzhen Denco Medical Co LtdChinaMaker———
TDV Dental LtdaBrazilMakerDIAMOND GLOSS · POLIGLOSS · SeptoDiamond Paste——
Huanghua Promisee Dental Co., LtdChinaMakerProphy Paste——
B.J.M. Laboratories LtdIsraelMakerSTEP-1 PumEtch Resin Tooth Bonding Agent——
Shanghai Dochem Industries Co., Ltd.ChinaMakerDental burs · Dental Polisher · Diamond Bur · Tungsten Carbide Bur——
Shanghai Jolly Industrial Co., Ltd.ChinaMakerProphy paste——
Pascal InternationalUnited StatesMakerRADENT PROPHY PASTE · Radent Prophy Paste - Non Fluoride——
Shanghai Lions Industrial Co., Ltd.ChinaMakerProphy paste——
Tangshan Zhengtong Exhibition Co., Ltd.ChinaMaker———
Anqing Clean Dental Instrument Technology Co LtdChinaMakerAGENT, POLISHING, ABRASIVE, ORAL CAVITY——
Jiangsu Yabaobao Medical Instrument Co.,Ltd.ChinaMaker———
Bioclear Matrix Systems, LLCUnited StatesMakerBlasting Powder · Dual-Color Disclosing Solution · Magic Mix PrePolish——
Intensiv SASwitzerlandMakerIntensiv UniglossPaste——
Henan Baistra Medical Devices LimitedChinaMakerAGENT, POLISHING, ABRASIVE, ORAL CAVITY——
Aadi Med Private LimitedIndiaMakerPro-Paste · Pumice powder (Different Grits) · Saphire (Diamond Polishing Paste) · Zirprophy——
Maquira Industria de Produtos OdontologicosBrazilMakerAIRON BICARBONATE · DIAMOND UNIVERSAL——
CDM Center of Excellence Ltd.ChinaMakerAgent, Polishing, Abrasive, Oral Cavity——
Gavin Biotechnology Co.,ltdChinaMakerDental Loupe · Surgical magnifying glass——
Zhejiang Yamei Medical Equipment Technology Co., Ltd.ChinaMakerProphy Paste——
Viarden Lab LLCUnited StatesMakerPROPHY PASTE VIARDEN LAB, DENT GLOSS, VIARGLOSS——
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——
Changsha Easyinsmile Intelligence Technology Co.,Ltd.ChinaMakerPhotosensitizer Models: High, Medium, Low——
EMS Electro Medical Systems SASwitzerlandMakerAIR-FLOW POWDER · AIRFLOW PLUS POWDER——
SKY DENT Corp for dental tradingUnited StatesMakerSKY DENT PROPHY PASTE CUPS - 1DERFUL PROPHY PASTE CUPS——
PHS Do Brasil LTDABrazilMakerPOTENZA ABRASIONE · POTENZA SPECCHI AL · POTENZA SPECCHI AL UNO DUE · POTENZA SPECCHI ARGILLA PRO · +1——
Peter Brasseler Holdings, LLCUnited StatesMaker———
ConamcoUnited StatesMakerMedental Prophy Paste——
Prisman GmbHGermanyMakerProphypowder FRESH · Prophypowder FRESH - Mint · Prophypowder PERIO PLUS · Prophypowder PERIO PLUS - Mint · +4——
Dedeco International, Inc.United StatesMakerAgent, Polishing, Abrasive, Oral Cavity——
Shenzhen Soga Technology Co. Ltd.ChinaMakerAIR-FLY——
VH Technologies LtdUnited StatesMakerDavid Hornbrook · DiaShine · Lucida——
Nomax Inc.United StatesMakerPRO CARE PROPHYLAXIS PASTE MIX——
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——
Liaoning Xinaite Technology Co.,LtdChinaMakerPolishing Paste——
Dr. Wittmann GmbH & Co. KGGermanyMakerAirflow Classic, Airflow Perio, Airflow Plus——
Eve Ernst Vetter GmbHGermanyMaker———
Span Packaging Services LLC dba Multi-Pack SolutionsUnited StatesMaker———
Zest Anchors, LLCUnited StatesManufacturer—262026
Cosmedent, Inc.United StatesRepacker / relabelerEnamelize · Porcelize272024
Lares ResearchUnited StatesManufacturerPastel Prophy Paste, Mint, Coarse Grit82022
DSI Dental Solutions LtdIsraelManufacturerDSI Prophylaxis Paste · Pumice Paste22025
Reliance Orthodontic Products, Inc.United StatesContract manufacturerFIRST AND FINAL · RESTORE322021
Dent Zar, Inc.United StatesRepacker / relabelerPolishers121996
Hu-Friedy Mfg Co., LLCUnited StatesContract manufacturerHuFriedyGroup · PWR Classic Powder · PWR Perio Powder82012
CNC Manufacturing, Inc.United StatesManufacturer—52007
Hager Worldwide, Inc.United StatesManufacturerAlmore Aluminum Oxide · Comp-Blitz22005
George Taub Products & Fusion Co., Inc.United StatesManufacturer—21986
DMG America, L.L.C.United StatesContract manufacturerAgent, Polishing, Abrasive, Oral Cavity - Kolorz12013
Jersey Dental SuppliesUnited StatesRepacker / relabelerGC MI PASTE PLUS · MI PASTE · NUPRO PROPHY PASTE——
Dentimed Sao Joao LLCUnited StatesRepacker / relabelerAngelus——
TitanLinks Logistics LLCUnited StatesRepacker / relabelerPolishing——
Patterson Companies, Inc.United StatesForeign exporterAGENT, POLISHING, ABRASIVE, ORAL CAVITY——
Soher Med LimitedHong Kong SAR ChinaForeign exporterdental——
STERIS CorporationUnited StatesContract sterilizerMedivance9720 (RG) - BAG 45S5——
Aspen Surgical ProductsUnited StatesContract manufacturerSymmetry Surgical——
Samtrade Supplies Inc.CanadaForeign exporterNupro Paste——
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——
CARGUS International Inc.United StatesRepacker / relabelerMARK3® Enamel Care Prophy Paste · MARK3® Prophy Paste——
LLD Care d.o.o.CroatiaForeign exporterEnamel, Prophy Paste——
AMD Medicom IncCanadaForeign exporterMedicom Denticare Pro-Polish——
Ortho Solutions LCUnited StatesContract manufacturer———
Bina LimitedBelizeForeign exporterABRASIVE——
Dentonics IncUnited StatesRepacker / relabelerMaster-Dent——
Shenzhen Upcera Digital Dental Technology Co., LtdChinaForeign exporterAbrasive material Pulverized Corundum; Polishing Paste——
Cordica Medical (Formally Team Technologies, Inc)United StatesContract manufacturer———
Axiodent Inc.United StatesRepacker / relabelerAxioGloss · AxioShine Fresh Fruit · AxioShine Fresh Mint · AxioShine Fresh Orange · +2——
HI Medical Co., Ltd.South KoreaForeign exporterDentsply——
Strauss & Co.IsraelManufacturer———
3D Dental Designs and Development LLCUnited StatesContract manufacturer———
Dylan Lucas International IncCanadaForeign exporter———
Mainline Medical Dental SupplyCanadaForeign exporter———
Oketz Logistics LLCUnited StatesRepacker / relabeler———
Zircon Plus LimitedIsraelForeign exporter———

510(k) clearances

Decided510(k)DeviceApplicant
11 Sep 2017K171189AIR-FLOW PLUS Prophylaxis powderE.M.S Electro Medical Systems S.A
26 Mar 2014K131760WHIP MIX PREPPIES PLUSWhip Mix Corporation
6 Aug 2012K121698NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMINDentsply International, Inc.
14 Mar 2011K103114OSSPRAY SYLC CROsspray, Ltd.
3 Feb 2011K102053BUTLER CALCI-FLOR PROPHYLAXIS PASTESunstar Americas, Inc.
21 Oct 2010K101104REMIN PROVoco GmbH
17 Jun 2010K100539PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDEPreventive Technologies, Inc.
12 Apr 2007K070854GC MI PASTE PLUSGC America Inc.
15 Dec 2006K062502OSSPRAY CLEANING COMPOUNDOspray, Ltd.
21 Nov 2006K062166ENAMEL PROPremier Dental Products Company
26 Oct 2004K042048GELATO PROPHYLAXIS PASTEDeepak Products, Inc.
20 Oct 2004K042200MI PASTEGC America Inc.
23 Aug 2004K041371BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMINNovamin Technology, Inc.
7 Jul 2004K040988ZIRCON-F PROPHYLAXIS PASTEPascal Co., Inc.
18 Jun 2004K033785PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDEPhilips Medical Systems International BV
9 Jun 2004K040661RADENT PROPHY PASTEPascal Co., Inc.
7 Jan 2004K033449PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICESProfessional Dental Technologies Therapeutics, Inc.
11 Jul 2003K024343BUTLER GUM PROPHY PASTE WITH NOVAMINUsbiomaterials Corp.
14 Dec 2000K002989PROCLUDEOrtek Therapeutics, Inc.
24 Mar 2000K000169NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSANDentsply Intl., Inc.
13 May 1999K9904823M CLINPRO PROPHY PASTE, MODEL 12611Minnesota Mining and Mfg. Co.
9 Feb 1999K973289RE NUPacific Rim Dental, Inc.
29 Jan 1999K983966NUPRO PROPHYLAXIS PASTE WITH FLOURIDE AND TRICLOSANDentsply Intl., Inc.
31 Mar 1997K962370PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDEChallenge Products, Inc.
15 Dec 1994K944575AQUAFRESH PLAQUE FIGHTING GUMSmithkline Beecham Consumer Healthcare Products
4 Nov 1994K942851SMILE INTEGRATED PROPHYLAXIS PASTE RINGSGermiphene Corp.
19 Apr 1994K940496PROPHY PASTEChallenge Products, Inc.
26 Jan 1994K935925VISION PROPHY PASTE WITH FLUORIDEBlock Drug Company, Inc.
16 Nov 1993K933893VISION PROPHY PASTE WITHOUT FLUORIDEBlock Drug Company, Inc.
5 Nov 1992K923675DENSPRO MEDIUM MINT PROPHY PASTETeledyne Getz
5 Nov 1992K923674DENSPRO COARSE MINT PROPHY PASTETeledyne Getz
9 Sep 1992K923020CLEANICHawe Neos Dental
16 Sep 1991K912945SATIN PROPHYLAXIS PASTEDentsply Intl., Inc.
10 Jun 1991K905303ABUTMENT GLOImplant Innovations International, Inc.
30 May 1991K911284PULPDENT DIAMOND POLISHPulpdent Corporation
28 Mar 1991K903986SWIRL PROPHYLAXIS PASTEBio-Medica Concepts
5 Dec 1990K904199HORIZON REGULAR ETCHING GELHorizon Chemical Co.
6 Sep 1990K901580PROPHY PASTEDentsply Intl., Inc.
29 Aug 1990K903003MPS DIAMOND POLISHING GELAbrasive Technology, Inc.
14 Aug 1990K896071ULTRA II PORCELAIN POLISHING PASTEShofu Inc
13 Aug 1990K901873DEGUFILL (R) POLISHING GELDegussa AG
1 Jun 1990K901973CP-3 DENTAL POLISHING MATERIALGresco Products, Inc.
16 Apr 1990K901052PULPDENT OIL FREE SURFACE PREPARATION PASTEPulpdent Corporation
14 Feb 1990K896661KEN'S PROPHY GEL - REGULARPulpdent Corporation
12 Oct 1989K894933PERLIDENTGermiphene Corp.
9 Jun 1989K891536ENAMEL MICROABRASION COMPOUNDPremier Dental Products Company
18 Apr 1988K875339JETPOLISHER AIRPOLISHING POWDERYoung Innovations Inc
12 Nov 1987K873686DIAMOND-LUSTER DENTAL POLISHING PASTEScientific Pharmaceuticals
2 Jul 1987K872251ABRASIVE DISC - POLISHING WHEELDentsply Intl., Inc.
1 May 1987K864226JOHNSON & JOHNSON STAINING REMOVING COMPOUNDJohnson & Johnson Professionals, Inc.
12 Feb 1987K865082PROPHY CARE SOLUTIONImd, Inc.
18 Nov 1986K864215PROPHY CARE SOLUTIONImd, Inc.
25 Sep 1986K863133PROPHY CARE PASTEImd, Inc.
12 Aug 1986K862912RENAMELIZE POLISHING PASTECosmedent, Inc.
21 May 1986K860843CHECK-UP PLAQUE FIGHTING GUMMinnetonka, Inc.
26 Mar 1986K854828SCI-PRO, PROPHYLAXIS PASTEScientific Pharmaceuticals
25 Mar 1986K854829DENSCO PROPHY PASTEScientific Pharmaceuticals
4 Feb 1986K854588INSTA-GLAZEGeorge Taub Products & Fusion Co., Inc.
31 Jul 1985K852814GLOSSY POLISHING PASTEScientific Pharmaceuticals
31 Jul 1985K851073CUPRIDENTBio Systems, Inc.
19 Jul 1985K852157TEMREX DENTAL POLISHING PASTEScientific Pharmaceuticals
1 Jul 1985K852489PROPOL DENTAL POLISHING PASTEScientific Pharmaceuticals
24 Aug 1984K843022KERR COMMAND ULTRAFINE POLISHING PASTEKerr Corporation (Danbury)
17 Aug 1984K842403LUSTER, DENTAL POLISHING PASTEScientific Pharmaceuticals
25 Apr 1984K840254DIAMOND LUSTREJelrus Technical Products Corp.
18 Oct 1982K822894DIABRITEAntraco, Inc.
14 Sep 1982K822142DIAGLAZEAntraco, Inc.
31 Aug 1981K812118NIMETIC POLISHING PASTEEspe-Premier Sales Co.
23 Apr 1981K810912ALLOY COMPOSITE POLISHMoyco Industries, Inc.
8 Apr 1981K810037DENTAL CHEWING GUM (SUGARLESS)Mcdennan Oral Products, Inc.
17 Jun 1980K801225DEN-MAT POLISHING PASTEDen-Mat Corp.
12 Sep 1979K791319MIRADAPT* POLISHING INSTRUMENTSJohnson & Johnson Professionals, Inc.
2 Jun 1978K780834PREVI DENT PROPHYLAXIS MINT NDCHoyt Laboratories
2 Nov 1977K771852NIMETIC POLISHING PASTEEspe GmbH (Us)
22 Aug 1977K771401PROPHY PASTEL.D. Caulk Co.
27 Sep 1976K760658DETARTRINE PSeptodont
27 Sep 1976K760656DETARTRINE ZMr. J. Garrick Eisenberg

Official records: FDA product classification for EJR · 21 CFR 872.6030.

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