Surgical devices · 21 CFR 872 Subpart E

Mouth Mirror

FDA device type “Mirror, Mouth”.

FDA codeEAXClass121 CFR872.4565Pathway510(k) exemptCategoryDental hand instruments
Companies listing it
357267 makers
Brands and models
641
510(k) clearances
120 in five years
FDA name
Mirror, Mouth
1980: 11982: 11983: 21984: 21986: 21994: 31995: 119801990200020102020

510(k) clearances per year, 1976–2026

Companies that list EAX

357 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Sybron Dental SpecialtiesUnited StatesMaker—2032026
KLS Martin SE & Co. KGGermanyMaker—432026
Inter-Med, Inc.United StatesMakerDisposable Mouth Mirrors · Metal Mirror Stem · Mouth Mirrors72026
Premium Plus (Dongguan) LimitedChinaMakerMouth mirrors, Intraoral Mirrors22025
Essential Dental Systems, Inc.United StatesMakerC-MOR152023
Ortho Organizers, Inc.United StatesMakerMirror · Photographic Stainless Steel Mirrors · PixSure Perfect82025
Shenzhen Rogin Medical Co., Ltd.ChinaMakerOral Mirror · Photographic Mirrors/mouth mirror, Defogging mouth mirror12025
DentalMaster (Xiamen) Medical Technology Co., Ltd.ChinaMakerMouth Mirror12026
Foshan SOCO Precision Instrument Co.,Ltd.ChinaMakerIntra-oralmirror · model:SCKJ01,SCKJ02,SCKJ03,SCKJ04,SCKJ05,SCKJ06,SCKJ07,SCKJ0812024
Pacific Care LimitedHong Kong SAR ChinaMaker—12025
Pulpdent CorporationUnited StatesMakerFLECTA1072021
Medicon EGGermanyMaker—92005
Hu-Friedy Mfg Co., LLCUnited StatesMakerHu-Friedy Mfg Co.,LLC82012
Premium Plus International LimitedHong Kong SAR ChinaMakerMouth mirrors, Intraoral Mirrors,mirrors32017
Integra LifeSciences CorporationUnited StatesMakerIntegra · MicroFrance · Miltex22014
Sunstar Americas, Inc.United StatesMakerG-U-M Lighted Mirror22013
Ranir, LLCUnited StatesMaker—22011
B&L Biotech Co., Ltd.South KoreaMakerB&L Jetip Instrument Micro Mirror · B&L Mirror · DMF4 · DMHG · +512006
Prestige Brands Holdings, Inc.United StatesMakerDentek Mouth Mirror12013
Sawbros Industries Pvt., Ltd.IndiaMakerBuccal Photographic Mirror · Occlusion Photographic Mirror · Photographic Mirror12017
Seilglobal CO., LtdSouth KoreaMakerMirror system12015
Allied Hill Enterprises, Ltd.Hong Kong SAR ChinaMakerbaby mouth mirror · DENTAL MIRROR12009
YETI Dentalprodukte GmbHGermanyMakerlot12018
Osung Mnd Co LtdSouth KoreaMakerBDMHL · BDMHLT · BDMHM · BDMHS · +35——
ErgoDenta ApSDenmarkMakerDouble End steel Handle, 8mm · ErgoLite Mirror handle, Citrus Orange · ErgoLite Mirror handle, Honey Brown · ErgoLite Mirror handle, Lemon Green · +66——
Zain's Medical ImagePakistanMakerDental Mirror · Mouth Mirror · Photographic Mirror——
Densol International (Private) LimitedPakistanMakerMouth Mirror Front Surface #4 Cone-Socket Pack of 10 · Mouth Mirror Front Surface #4 Pack of 10 · Mouth Mirror Front Surface #5 Cone-Socket Pack of 10 · Mouth Mirror Front Surface #5 Pack of 10 · +4——
Metro MedicalPakistanMakerHandles for Dental Mirrors · Mouth Mirrors, Front Surface, 16 mm · Mouth Mirrors, Front Surface, 18 mm · Mouth Mirrors, Front Surface, 20 mm · +12——
Signor Seven InternationalPakistanMakerErgonomic Handle Cone Socket SKU 10-112-CS · Ergonomic Handle Simple Stem SKU 10-112-SS · Ergonomic Handle With Cone Socket 5# Mirror 5 Pack SKU 10-118-CS · Ergonomic Handle With Cone Socket Mirror SKU 10-112-CS · +17——
Shanghai Kangqiao Dental Instruments FactoryChinaMakerMicro Mirror WY1/WY2/ WJ1/WJ2 · Mirror 1SZZP 4/3SZZP 4/SZZP 5/LSZP 5/L2SZP 5 · Mouth mirrors · Mouth mirrors 3# JFP plain · +18——
株式会社YDMJapanMakerContraster for Anterior L · Contraster for Anterior S · Contraster for Posterior · Photographic Mirror Crystal for Buccal & Lingual · +18——
Debo Medical Technology (Shijiazhuang) Co., Ltd.ChinaMakerDental Mouth Mirror · Disposable Dental Instrument Kit · MIRROR. MOUTH · Oral Observer (Intraoral Endoscope)——
B. Ali ImpexPakistanMakerBALI · DOCTOR NICE——
Prodont-HolligerFranceMakerArticle N° 017-24803 - MICRO MIR 7/2 MM REC CS FS · Article N° 7090011 - MP4522 - TI M.MIRRORS · Article N° 7090012 - MP4524 - TI M.MIRRORS · Article N° 7090013 - MPP8524 - DS TI MIRRORS · +19——
Dental StudioSouth KoreaMakerMirror & Holder——
Shenzhen Denco Medical Co LtdChinaMakerMicro Mirror,Oral Mirror · Photographic Mirrors/mouth mirror; Defogging mouth mirror——
Huanghua Promisee Dental Co., LtdChinaMakerdisposable mirrors——
Technimen SkillersPakistanMakerDENTAL MIRROR · LARYNGEAL MIRROR · MOUTH MIRROR · POST NASAL MIRROR——
Falcon Surgical Co. (Pvt.) Ltd.PakistanMakerMIrror——
Pomee CorporationPakistanMakerMirror Handles · Mouth Gags & Cheek Retractor——
Commic SurgicoPakistanMakerLarangiel Mirrors · Mouth Mirror Magnifying · Mouth Mirror Plain · Mouth Mirror Rhodium——
Endo Tech InstrumentsPakistanMakerMirror for dental · Mirror Handle——
Shanghai Alwings Medical Instrument Co.,Ltd.ChinaMakerMouth Mirror——
Medcave Private LimitedPakistanMakerMouth Mirrors——
Panorama InternationalPakistanMakerMIRROR, MOUTH——
Shanghai Dochem Industries Co., Ltd.ChinaMakerDisposable Mouth Mirror——
Accompany SurgicalPakistanMakerMOUTH MIRROR——
Shanghai Jolly Industrial Co., Ltd.ChinaMakerCheek retractor · Disposable dental kits (probe, mirror, tweezer) · Disposable mirror · Mirror, mouth · +2——
Pascal InternationalUnited StatesMakerRetrax System Mirror——
Comfort Surgical InstrumentsPakistanMakermouth mirror——
Aesculap AGGermanyMakerAesculap——
Shanghai Lions Industrial Co., Ltd.ChinaMakerCheek retractor · Disposable Dental kits (probe, mirror, tweezer) · Disposable mirror · MIRROR, MOUTH · +2——
Adolf Schweick Hardt GmbH & CoGermanyMakerMOUTH MIRRORS——
Hangzhou Westlake Biomaterial Co., Ltd.ChinaMakerMirror · Mirrors, Mouth, Orthodontic · Mirrors, Mouth, Orthodontic (All types of Orthodontic Mirror( Stainless and Glass))——
Beyes Dental IncCanadaMakerBeyes Dental Mirror——
Confident InstrumentsPakistanMakerArtman Instruments——
Tangshan Zhengtong Exhibition Co., Ltd.ChinaMakerDisposable Mouth Mirror——
Denta Craft InstrumentsPakistanMakerMOUTH MIRROR——
ZOGEAR Medical Co., Ltd.ChinaMakerMIRROR, MOUTH——
Hilbro Instruments (Pvt) LtdPakistanMakerHILBRO INSTRUMENTS MOUTH MIRROR · MIRROR, MOUTH——
Medisporex Private LimitedPakistanMakerMEDIS——
Solventum US LLCUnited StatesMakerMouth Mirror · Unitek——
Dentag SRLItalyMakerDENTAG——
Garish ApparelsPakistanMakerTamzon Instruments Inc.——
Acme EnterprisesPakistanMakerTBS Dental——
SurgicraftsPakistanMakerEAX / MIRROR, MOUTH——
W.H. Holden Inc. DBA H & H CompanyUnited StatesMakerMOUTH MIRRORS——
Acheron Instruments (Pvt.) Ltd.PakistanMakerMouth Mirrors——
Hubei Guarddent Medical Technology Co.,LtdChinaMakerdental mouth mirror——
Harf IndustriesPakistanMakerMirror Handle,Dental Mirrors——
Silver Plus Corp.PakistanMakerMOUTH MIRROR——
NuCare LLCUnited StatesMakerNuCare intraoral occlusal mirror——
Shanghai Medical Instruments (Group) Ltd. Corp.ChinaMakerMIRROR DENTAL——
SurgiscapePakistanMakerMIRROR, MOUTH——
Cangzhou Lankang Medical Instruments Developing Co., Ltd.ChinaMakerDisposable Dental Instrument Kit——
Guangzhou Xinuo Technology Co., LtdChinaMakerDisposable Dental Instrument Kit——
Jiangsu Yabaobao Medical Instrument Co.,Ltd.ChinaMakerDisposable dental mirror——
Maryam TradingPakistanMakerMIRROR, MOUTH——
Garana Industries (PVT) LtdPakistanMakerDental Hand Instrument · Handle with Mirror · Laryngeal Mirror · Mirror Handle · +1——
Shenzhen Senlede Technologies Co., LtdChinaMakerDisposable Dental Instrument Kit——
Towne Brothers (Pvt) LtdPakistanMakerEAX - MIRROR, MOUTH——
Choose Surgical InstrumentsPakistanMakerMIRROR, MOUTH——
Lohar Medical CompanyPakistanMakerEAX / MIRROR, MOUTH · Mirror Handle for teeth——
Mident LtdUnited KingdomMakerMouth Mirrors——
READY SET IMPORT dba Mynt ProfessionalUnited StatesMakerOral Mirror——
Acme Commercial Ways Ltd.PakistanMakerMIRROR, MOUTH——
Medline Industries, LPUnited StatesMakerMedline / Konig Mirror, Mouth——
Nadir & Co.PakistanMakerDental Mirror · Stainless Steel Mirrors——
Y. Z. CorporationPakistanMakerYZ Dental Mouth Mirrors——
Astar Orthodontics IncChinaMakerstailess steel photo mirrors, double polished,set · stainless steel photo mirror, oclussional · stainless steel photo mirrors, buccal · stainless steel photo mirrors, lingual · +1——
Daddy D ProPakistanMakerMouth Mirrors——
Hefei Xingcheng Sanitary Products CO.,LTDChinaMakerDental Mirror / Probe / Tweezer——
Mount Blonck TradingPakistanMakerMIRROR, MOUTH · Mouth Mirror Cone Socket Front Surface #4 and # 5.——
TeleflexUnited StatesMakerMULTIPLE MOUTH MIRRORS——
Crown Surgical Corp.PakistanMakerCROSURG——
HuangHua DK Dental Co., LTD,ChinaMakerMouth Mirrors——
SurjexPakistanMakerMIRROR, MOUTH——
Zhejiang Jasmine Oralcare Products Co., Ltd.ChinaMakerDental Mirror · MirrorSoft No.4 Mirror · MirrorSoft No.5 Double Mirror · MirrorSoft No.5 Mirror · +1——
Dimeda Instrumente GmbHGermanyMakerDIMEDA——
Pilotis Tech LLCUnited StatesMakerIntrace USA——
B. Braun Medical Industries Sdn. BhdMalaysiaMakerAesculap——
Henan Baistra Medical Devices LimitedChinaMakerMIRROR, MOUTH——
HILBRO International (Pvt) Ltd.PakistanMakerHilbro Intl mouth mirror——
Medesy SrlItalyMakermedesy——
Meed Skills SurgicalPakistanMakerMeed Skills Surgical——
Hangzhou Wise Medical Device Co.,LtdChinaMakerMirrors Mouth Orthodontic (all types of Orthodontic Mirror Glass and Stainless steel)——
Mian Shahid Corp.PakistanMakerMIRROR, MOUTH——
Zirc Dental Products IncUnited StatesMakerCrystal HD® Resin Mouth Mirror Screw-On Head Cone Socket · Crystal HD® Resin Mouth Mirror Screw-On Head Cone Socket Double-Sided · Crystal HD® Resin Mouth Mirror Screw-On Head Simple Stem · Crystal HD® Resin Mouth Mirror Soft Grip Double-Sided · +4——
Gavin Biotechnology Co.,ltdChinaMakerDental Anti-fog Mirror——
Volgo Care International (Private) LimitedPakistanMakerVOLGOCARE——
Zhejiang Yamei Medical Equipment Technology Co., Ltd.ChinaMakerMouth Mirror, Contrastor, Photographic Mirror——
New Phenix Home Products Manufactory Co LtdChinaMakerDental Mirror——
Xiantao S&J Protective Products Co., LtdChinaMakerPhotographic Mirror; Mouth Mirror——
Dentech Corp.JapanMakerMETAL MIRROR——
M.M Dental CorpPakistanMakerCone Socket · Front Surface · Front Surface, #4 · Mirror Heads · +1——
SGS Export Intl.PakistanMakerMirror, Mouth——
Spartech Instruments & Co.PakistanMakerMIRROR, MOUTH——
Dr Frigz International Pvt LtdPakistanMakerMIRROR, MOUTH——
G.S.T. Corporation LimitedIndiaMakerGold Cross · GSTC · Heuer——
MCTBIO Co., LtdSouth KoreaMakerMIRROR/ Mouth——
Med2B Ltd.GermanyMakerMIRROR, MOUTH——
Melpex Beauty InstrumentsPakistanMakerMIRROR, MOUTH——
Shandong Hengfeng Kerui Medical Equipment Co., LtdChinaMakerMouth Mirror——
Shenzhen Jie Bishi Technology Co., LTDChinaMakerdental mirror · Oral endoscopy · R60,R70,R80,R90,R10,R11,R12,R13,R14,R15,R16,R17,R18,R19,R20,R30,R40,R50 · 401,402,403,408,406,I60,I70,I80,I90,I10,I11,I12,I13,I14,I15,I16,I17,I18,I19,I20——
Armatech InternationalPakistanMakerMIRROR, MOUTH——
Central Surgical Co. Pvt. Ltd.PakistanMakerMouth Mirrors——
DongGuan Magenta Medical Equipment Co., Ltd.ChinaMakerDarkdec Intraoral Camera · Macdel Mouth Mirror · Mouth Mirror · 19:30 PM Intraoral Camera · +1——
Sabokay IndustriesPakistanMakerMirror, Mouth——
Tianjin Water Source Tech Co., Ltd.ChinaMakerMirror, Mouth——
Armor Dental CorporationUnited StatesMakerMirroSoft™ Delta Mirror · MirroSoft™ No. 4 Mirror · MirroSoft™ No. 5 Double Mirror · MirroSoft™ No. 5 Mirror · +1——
Changsha Nice Medical Instrument Limited CompanyChinaMakerNiceortho Mirror, Mouth——
Darleys Surgical Co.PakistanMakerMIRROR, MOUTH——
Elite Dental LabChinaMakerMouth Mirror——
Fabryka Narzedzi Medycznych CHIRMED Marcin Dyner Spolka KomaPolandMakerMouth Mirror CHIRMED——
Hazel EnterprisesPakistanMakerMIRROR, MOUTH——
Shandong Zhushi Pharmaceutical Group Co., LtdChinaMakerDisposable Dental Instrument Kit——
SurgikarePakistanMakerMIRROR, MOUTH——
T.A. Walthem & CompanyPakistanMakerMIRROR, MOUTH——
Washington Surgical InternationalPakistanMakerMIRROR, MOUTH——
Zhongshan Xinhe Co.,LtdChinaMakerMirror, Mouth——
Ashtel Studios, Inc.United StatesMakerDental Mirror——
Diligent Medical SerPakistanMakerMirror Mouth, Dental Hand Instrument——
Hebu Medical GmbHGermanyMakerLaryngeal mirror, cone socket, magnifying——
Infirmary Medical SuppliesPakistanMakerMIRROR, MOUTH——
Madina Surgical WorksPakistanMakerMIRROR, MOUTH——
Plasdent Shanghai Co., Ltd.ChinaMakerMirror, Mouth——
Applied Dental Inc DBA AD SurgicalUnited StatesMakerE&P · i-pak——
Hexamed Pvt LtdPakistanMakerMouth Mirror——
Nawaz and SonsPakistanMakerEAX / MIRROR, MOUTH——
Richbolt EnterprisesPakistanMakerRICHBOLT ENTERPRISES——
Wellmed Dental Medical Supply Co., Ltd.ChinaMakerMIRROR, MOUTH——
Coral Healthcare Products Manufacturer Co., Ltd.ChinaMakerDENTAL MIRROR, Brand: CORALCLEAN, USOP, SKY DENTAL, ALLURE ORTHO, PLATYPUS, O&S DENTAL; Model: D603, D653, S451, S452 · DENTAL MIRROR, Brand: CORALCLEAN, USOP, SKY DENTAL, ALLURE ORTHO, PLATYPUS, O&S DENTAL; Model: S453, DM01, AC01 · DENTAL MIRROR, Brand: CORALCLEAN, USOP, SKY DENTAL, ALLURE ORTHO, PLATYPUS, O&S DENTAL; Model: S815, S811, S951, D600——
Emerald InstrumentsPakistanMakerMIRROR, MOUTH——
Guangzhou Cheer-U Material Technology Co., LtdChinaMakerMouth Mirror——
Jiangsu Province Yangzhou Shuguang Toothbrush ManuChinaMakerPlastic Mouth Mirror——
Laparomed Private LimitedIndiaMakerMOUTH MIRROR AND HANDLES——
Sabri IndustriesPakistanMakerMIRROR, MOUTH——
Zepf Medical InstrumGermanyMaker———
Zhejiang Mediunion Healthcare Group Co LtdChinaMakerdental mirror——
Atria Co.South KoreaMakerAtria——
Chengdu Sani Medical Equipment CO.,LTD.ChinaMakerDental Mirror · Micro Mirror——
CM Instrumente GmbHGermanyMaker———
Concise EnterprisesPakistanMakerDisposable Mouth Mirror, Double-Sided Mouth Mirror, Rear Surface Mirror · Plain Mouth Mirror, Front Surface Mirror, Concave Mouth Mirror——
Mts Brothers Surgical InstrumentsPakistanMakerMIRROR, MOUTH——
NR Surgical CompanyPakistanMakerMIRROR, MOUTH——
Robinson Healthcare LimitedUnited KingdomMakerInstrapac——
Sino Ortho LimitedChinaMakerphotographic mirror——
Asanus Medizintechnik GmbHGermanyMakerASANUS——
ClikTech, LLCUnited StatesMakerFlipMirror——
SITEC (Pvt.) Ltd.PakistanMakerMouth Mirror——
Ameda Instruments CompanyPakistanMakerMouth Mirrors——
ASA DentalItalyMakerMouth Mirror——
Shanghai D-One International Co., Ltd.ChinaMakerMouth mirror——
Shenzhen Ainengke Electronics Co., Ltd.ChinaMakerDental mirro——
Garnet DentechSouth KoreaMakerMouth Mirror——
Hefei Jingcheng Plastic Products Co. LtdChinaMakerDental Kit——
Shummi Enterprise Co, LtdTaiwanMakerMOUTH DENTAL——
Ultra Surgical (Pvt.) Ltd.PakistanMakerMIRROR, MOUTH——
American Angle Ortho, LLCUnited StatesMakerAurora Stainless Steel Mirrors, Aurora Glass Mirrors——
Anhui JM Healthcare Products Co.,Ltd.ChinaMakerDental pack, Disposable Mouth Mirror, Mouth Mirror——
Dhef Inc.TaiwanMakerPOLYMAS Mouth Mirror & Accessories, Mirror Defogger, Dental Hand Instrument——
Hangzhou DTC Medical Apparatus Co., LtdChinaMakerDental Mirror;DTC;Orthodontics——
Peter Brasseler Holdings, LLCUnited StatesMaker———
Shenzhen Baotonghui Industrial Co.,LtdChinaMakerDental tools——
Swengg CoPakistanMakerDental / Mouth Mirror——
Weihai Jieshi Commodity Manufacture Co., Ltd.ChinaMakerdental mirror——
Yangzhou Haiwang Toothbrush FactoryChinaMakerDental Mirror——
Zhejiang YO Medical Technology Co., LtdChinaMakerDENTMAS; GLOBAL DENTAL; Orthodontics; TEXDENT——
Amedcon Medical Technology (Shenzhen) Co., Ltd.ChinaMaker———
E Hahnenkratt GmbHGermanyMakerHAHNENKRATT-MOUTH MIRRORS——
INKA Surgical InstrumentsAustraliaMakerN/A——
Quality Concept (Pvt.) Ltd.PakistanMakerMIRROR, ,MOUTH——
Weihai Huihai Commodity Manufacture Co., Ltd.ChinaMakerMIRROR, MOLITH——
Yangzhou Royal Home Products Manufacture Co., Ltd.ChinaMakerMirror, Mouth——
Anhui Ares Medical Technology Co.,Ltd.ChinaMakermouth mirror——
Dufner Instrumente GmbHGermanyMakerMIRROR, MOUTH——
Jay-MedPakistanMakerMIRROR, MOUTH——
M.J. Instruments Company (Pvt.) Ltd.PakistanMakerDENTAL MIRROR WITH HANDLE SIZE FIG.3 16MM DENTAL MIRROR WITH HANDLE SIZE FIG.5 20MM DENTAL MIRROR WITH HANDLE SIZE FIG · LARYNGEAL MIRROR——
Shenzhen Topinnor Technology Co.,ltdChinaMakerDentist Tools, model: D1,D2,D3,D4,D5,D6——
Skill To Tech InternationalPakistanMakerMIRROR, MOUTH——
Anhui MedPurest Medical Technology Co LtdChinaMakerOral mirrorsdontoscope——
Cixi Qimei Combination Tool Packing FactoryChinaMakerMouth Mirror——
Global Dent Aids Pvt. Ltd.IndiaMaker———
Pesitro Healthcare Products Co., Ltd.ChinaMaker———
Prima Dental GroupUnited KingdomMaker———
Sobytek Instruments Co.PakistanMakerdental mirror——
Verdent Ltd.PolandMakerVerdent mouth mirrors——
Yangzhou Yichuan Plastic Technology Co., Ltd.ChinaMakerDental Mirror——
Anqing Kangmingna Packaging Co.,LtdChinaMakerOral mirrorsdontoscope——
Ascentcare Dental ProductsUnited StatesMakerRadical Reflector——
Beijing ZKSK Technology Co., Ltd.ChinaMakerThe Mouth Mirror——
Chewink Corp.TaiwanMakerMouth Mirror——
Hubei Lanbin Medical Group Co., Ltd.ChinaMakerMIRROR, MOUTH——
J&J InstrumentsUnited StatesMaker———
M R Utility products Private limitedIndiaMakerDenTek Oral Care Kit——
Perfect Group Corp. Ltd.ChinaMaker———
Precision Beauty & Dental Instruments LLCUnited StatesMakerPrecision Dental Instruments——
RC Consolidated Services, IncUnited StatesMakerRCM Mirror, Mouth · RidgeCura Medical Mirror, Mouth——
Roeder Dentalinstrumente GmbH & Co. KGGermanyMakerCheek Retraction Mirror · Clarima · EC-Aktiv · HR-Front · +2——
Yangjiang Kaimi Import Export Co.,LtdChinaMakerMIRROR, MOUTH——
Hainan Lunarsea Personal Care Supplies Sdn. Bhd.ChinaMakerDental Mirror——
Hilbro Pvt LtdPakistanMakerMIRROR, MOUTH——
Myka Sons & CoPakistanMakerMonth Mirrors——
QSA SurgicalPakistanMaker———
A Fone SurgicoPakistanMakerMIRROR, MOUTH——
IPB IncUnited StatesMakerMouth Mirror——
Kohler Medizintechnik GmbHGermanyMaker———
Shenzhen Yuechuan trade Co., Ltd.ChinaMakerMouth Mirror——
Foshan Fengyun Medical Technology Co., Ltd.ChinaMakerDental Mouth Mirror——
Illuco Co, LTDSouth KoreaMakerIDM-1C14-B · IDM-1C14-DB——
Shun HO Industrial Ltd.ChinaMakerWalgreens, CVS——
ACME Tooling Technology Co., Ltd.TaiwanMakerMotranser——
Crystalmark Dental Systems, Inc.United StatesMakerAbrasion Resistant Mirror——
Dalian Wenjing Wooden Industry Co., Ltd.ChinaMakerMIRROR, MOUTH——
Hong Yu Kang Technology (Guangdong) Co., Ltd.ChinaMakerVisual dental mirror, Y1, Y2, Y3, Y4, Y5, Y6, Y7, Y8, Y9, Y10——
Infitek Co., Ltd.ChinaMakerENT&Ophthalmology Diagnostic Equipment · Mouth Mirror——
Madhi CorporationPakistanMakerMirror handle——
Narang Medical LtdIndiaMakerNET——
OPCOM Inc.TaiwanMakerDuck MIRROR, MOUTH——
Puli Healthcare (Thailand) Co., Ltd.ThailandMakerDisposable dental mirror——
Shenzhen Jiding Electronic Co.,ltd.ChinaMakerDental mirror, Visual medical grade endoscope, Video laryngoscope, Visual magnifier——
Tianchang Roujie Brushing Industry Co., Ltd.ChinaMakerDental Mirror——
Ultralight Optics Inc.United StatesMakerAirBlade AirMirror——
Dongguan Shun King Company LimitedChinaMaker———
Evaporated Metal Films Corp.United StatesMakerRiofoto——
I-Dent Innovations for Dentistry SASwitzerlandMakerEver clear II——
Labpeak Co.,LtdChinaMakerMouth Mirror——
Phoenix Instruments, Inc.United StatesMaker———
RNDent IP Ltd.IsraelMakerTANIGO——
Scitek Global Co.,LtdChinaMakerMouth Mirror——
SmartMirror dentalUnited StatesMakerSmartMirror——
USTOMED INSTRUMENTE GmbH & Co. KGGermanyMaker———
Xinhua Surgical Instrument Co.,Ltd.ChinaMaker———
Avalign TechnologiesUnited StatesMaker———
Berger Surgical Medical Products GmbHGermanyMaker———
Coda Resources Ltd., Heze ChinaChinaMaker———
Devemed GmbHGermanyMaker———
DEWIMED Medizintechnik GmbHGermanyMaker———
Gulmag InternationalPakistanMaker———
Helmut Zepf Medizintechnik GmbHGermanyMaker———
Nextcon InternationalPakistanMaker———
Sinntech Medical (Private) LimitedPakistanMaker———
Sion Biotext Medical LtdIsraelMaker———
Sion Biotext Mexico, S.A.P.I. De C.V.MexicoMaker———
SMD Manufacturing LLCUnited StatesMaker———
Tekno-Medical Optik-Chirurgie GmbHGermanyMaker———
Yangzhou Xintaiyang Plastic Daily Chemical Co., Ltd.ChinaMaker———
DiaDent Group InternationalSouth KoreaForeign exporterMiracle Suction242026
B.t.i. BiotechnologySpainForeign exporter—142024
American OrthodonticsUnited StatesContract manufacturerPhotographic Mirror442026
Young Innovations IncUnited StatesContract manufacturerAEI Cone Socket Mirrors · DENTICATOR DISPOSABLE MOUTH MIRROR232025
Parkell, IncUnited StatesContract manufacturer—582025
Imicryl Dis Malzemeleri Sanayi VE Ticaret ASTürkiyeManufacturerDENTAL MIRROR52022
Biomet MicrofixationUnited StatesManufacturerDental Mirror82021
Henry Schein, Inc.United StatesForeign exporterMirror Disposable Dental82004
DentamericaUnited StatesRepacker / relabelerPOLYMAS Mouth Mirror & Accessories, Dental Hand Instrument, Mirror Defogging System42010
Jedmed Instrument Co.United StatesRepacker / relabelerMIRROR MICRO RNODIUM41981
G&H Wire CompanyUnited StatesContract manufacturern/a22008
Storz AM Mark GmbHGermanyContract manufacturerCheek retractor mirror · Mirror · Mouth mirror22008
Aesculap, Inc.United StatesListerAesculap22006
DB Orthodontics LimitedUnited KingdomForeign exporterDB Orthodontics Mirror22010
GC OrthodonticsUnited StatesManufacturerMirrors22015
Engineered EndodonticsUnited StatesRepacker / relabelerCialegese Mouth Mirrors12019
Kwang Myung Daicom, Inc.South KoreaManufacturerMirror12011
Sotera Health LLCUnited StatesContract manufacturerMirror, Mouth——
One DashcorpUnited StatesRepacker / relabelerValdent USA #4 Stainless Steel Mouth Mirror Head, Cone Socket · Valdent USA #4 Stainless Steel Mouth Mirror Head, Simple Stem · Valdent USA #5 Stainless Steel Mouth Mirror Head, Cone Socket · Valdent USA #5 Stainless Steel Mouth Mirror Head, Simple Stem · +1——
Wuxi Lyusmile Imp and Exp Co.,ltdChinaPrivate-label distributorautoclavable mouth mirror · dental mouth mirror · disposable mouth mirror · mouth mirror with scale——
Dentimed Sao Joao LLCUnited StatesRepacker / relabelerangelus——
TitanLinks Logistics LLCUnited StatesRepacker / relabelerMouth Mirrors——
Jmu Dental, Inc.United StatesRepacker / relabelerMATERIAL, IMPRESSION TRAY, RESIN——
Patterson Companies, Inc.United StatesForeign exporterPatterson® Mouth Mirrors——
Soher Med LimitedHong Kong SAR ChinaForeign exporterMirror——
Daiso USA LLCUnited StatesForeign exporterPointed Toothbrush and Dental Mirror.——
STERIS CorporationUnited StatesContract sterilizer———
Practicon, Inc.United StatesManufacturerDisposable Mouth Mirror · Mirror Cotton Holders · Nice Touch Mouth Mirrors · Practicon Classic Disposable Mouth Mirrors · +3——
Aspen Surgical ProductsUnited StatesContract manufacturerSymmetry Surgical——
Cislak Manufacturing, Inc.United StatesContract manufacturerCislak · Zoll Dental——
International Orthodontics Services. PCUnited StatesRepacker / relabelerPhotographic Mirror——
Premium Plus DentalUnited StatesListerPremium Plus Mouth Mirrors——
Nordent MFG., Inc.United StatesContract manufacturerNordent Mirrors——
Ortho Arch Company IncUnited StatesRepacker / relabelerPatient Care Kits Disposable Mirrors · Super Glass Mirror: Occlusal, Lingual and Buccal——
Csy International LLCUnited StatesRepacker / relabelerJ&J ORTHODONTICS——
Diadent Group Intl., Inc.CanadaForeign exporterMiracle Suction——
GoldenDentUnited StatesRepacker / relabelerdental mirror——
PDT Inc.United StatesContract manufacturer———
Yizur LtdHong Kong SAR ChinaForeign exporterMouth Mirrors——
TBS DentalUnited StatesRepacker / relabelerTBS INOX USA——
Wise Linkers LLCUnited StatesRepacker / relabelerArtman Instruments——
J. Morita MFG Corp.JapanContract manufacturerBEACH MOUTH MIRROR——
Sklar CorporationUnited StatesRepacker / relabelerMouth Mirror——
Unisource Shanghai Ltd.ChinaForeign exporterDENTAL MIRROR, DENTAL MOUTH MIRROR · MirrorSoft No.5 Double Mirror · MirrorSoft No.5 Mirror · MirrorSoft TearDrop Mirror · +1——
battechUnited StatesRepacker / relabelerdental shaped hand mirror——
Maxill Inc.United StatesForeign exporterMaxill——
Shanghai MU PROMOTIONS Co., Ltd.ChinaForeign exporterDisposable Dental Mirror——
Ortho Solutions LCUnited StatesContract manufacturerPhotographic Mirror——
White Oak Orthodontic ProductsUnited StatesRepacker / relabelerInfinity——
YCH Distripark Sdn BhdMalaysiaForeign exporterAesculap——
E A Beck & CompanyUnited StatesRepacker / relabelerMOUTH MIRROR——
Plasdent CorporationUnited StatesRepacker / relabelerDental Mirror, Mouth Mirror, Photography Mirror, Photo Contrastor——
Boen Healthcare Co LtdChinaForeign exporterOral mirrorsdontoscope——
US Orthodontic ProductsUnited StatesRepacker / relabelerMouth Mirror——
Esthetic Orthodontic Company of America LLCUnited StatesRepacker / relabelerd.Mistify——
Shanghai Hua EN Industrial Co. Ltd.ChinaForeign exporterOral Mirror——
Cordica Medical (Formally Team Technologies, Inc)United StatesContract manufacturerMOUTH MIRROR · Team Technologies——
Palmero HealthcareUnited StatesRepacker / relabeler———
Orthone INC.United StatesRepacker / relabelerorthone——
Tim J. PrusaitisUnited StatesContract manufacturerPRU-DENT——
E/T Endodontic Technologies, Ltd.CanadaForeign exporter———
Peak Implements IncUnited StatesRepacker / relabelerMIRROR, MOUTH——
Sanicure BVNetherlandsForeign exporter———
Tess Oral HealthUnited StatesManufacturerTess Oral Health Mouth Mirror——
Trinity Sterile IncUnited StatesManufacturerLaryngeal Mirror——
Zapalign LLCUnited StatesRepacker / relabeler———
Oriental International Supplies LimitedHong Kong SAR ChinaForeign exporterStainless Steel Photographic Mirror——
Tianjin Medicines & Health Products Imp. & Exp. Corp.ChinaForeign exporterMIRROR, MOUTH——
Enova Illumination Inc.United StatesListerMotranser——
SurgiPros LLCUnited StatesRepacker / relabelerSURGIPROS——
Hangzhou HaiZhu MIM products Co., LtdChinaForeign exporterMOUTH MIRROR——
simex Medizintechnik GmbHGermanyRepacker / relabelerMirror, Mouth——
Tender Corporation d/b/a Adventure Ready BrandsUnited StatesRepacker / relabelerDental Mirror——
Vermont Manufacturing Services, Inc.United StatesRepacker / relabelerAdventure Ready Brands——
Boss Instruments LtdUnited StatesRepacker / relabelerBoss Mirror——
Magnum MedicalUnited StatesRepacker / relabelerDental Mirror——
Novo Surgical Inc.United StatesRepacker / relabeler———
Guang Zhou MedClear Medical Device Service Co.,Ltd.ChinaContract sterilizerE&P; i-pak——
Shenzhen king medical packaging sterilization service Co.ltdChinaContract sterilizerSterilized I Pak -Mirror——
Aid United International Co., LimitedChinaForeign exporter———
Olulo LLCUnited StatesRepacker / relabeler———
3D Dental Designs and Development LLCUnited StatesContract manufacturer———
Amnotec International Medical GmbHGermanyRepacker / relabeler———
Shanghai Medicines & Health Products Imp. & Exp. Co., Ltd.ChinaForeign exporterDISPOSABLE MOUTH MIRROR——
Coda Resources LtdUnited StatesLister———
INVIDIA Medical GmbH u CO KGGermanyRepacker / relabeler———
J.M. Murray Center, Inc.United StatesRepacker / relabeler———
Mainline Medical Dental SupplyCanadaForeign exporter———
Oketz Logistics LLCUnited StatesRepacker / relabeler———
Vehu Medical Instrumente GmbHGermanyRepacker / relabeler———

510(k) clearances

Decided510(k)DeviceApplicant
16 Feb 1995K946073ORALVUE DENTAL MIRRORHines Group , Ltd.
2 Sep 1994K935906RANIR PLAX RXRanir/Dcp Corp.
18 May 1994K941574RETRO MIRRORUnion Broach, Div. Moyco Industries, Inc.
3 Feb 1994K935687NILDentalsafe Systems Pty., Ltd.
30 Oct 1986K863767GLASS MOUTH MIRRORS, REUSABLEThe Medical Group, Inc.
30 Oct 1986K863766DISPOSABLE MOUTH MIRRORS, SINGLE USE ONLYThe Medical Group, Inc.
7 May 1984K833310FOGCUTTER DENTAL MOUTH MIRRORHti, Inc.
25 Apr 1984K841199FIBERGLASS MOUTH MIRRORSHenry Schein, Inc.
22 Dec 1983K833429PERI MIRROR/SALIVA EJECTORDentec, Inc.
6 Apr 1983K830777ELECTRIC MOUTH MIRRORAlmore Intl., Inc.
6 Jul 1982K821777BEACH MOUTH MIRRORPacific Dental Corp.
8 May 1980K800919ORAVIEW BY WATER PIKTeledyne, Inc.

Official records: FDA product classification for EAX · 21 CFR 872.4565.

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