Miscellaneous devices · 21 CFR 872 Subpart G

Polishing Agent Wheel

FDA device type “Wheel, Polishing Agent”.

FDA codeEJQClass121 CFR872.6010Pathway510(k) exemptCategoryPolishing & prophylaxis
Companies listing it
5937 makers
Brands and models
136
510(k) clearances
10 in five years
FDA name
Wheel, Polishing Agent
1978: 119801990200020102020

510(k) clearances per year, 1976–2026

Companies that list EJQ

59 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Ultradent Products, Inc.United StatesMakerJiffy Composite Pol. Brush (ptd) · Jiffy Composite Pol. Brush (reg) · Jiffy Goat Hair Brush · StarBrush952026
Kuraray Noritake Dental, Inc.JapanMakerNORITAKE DENTAL SUPPLY CO. LTD322025
Dent4You AGSwitzerlandMakerKENDA52026
Premier Dental Products CompanyUnited StatesMakerDiamond Twist SCL™ · Diamond Twist SCO™282026
Dentscare LtdaBrazilMakerDiamond · Diamond Flex · Diamond Pro102024
Coltene/Whaledent AGSwitzerlandMakerAlpen Ceramic Plus ShapeGuard · Alpen Composite Plus ShapeGuard · Alpen Polishers · Alpen Zirconia Plus ShapeGuard · +47452022
Garrison Dental Solutions LLCUnited StatesMakerRally™32024
Micerium S.P.A.ItalyMakerENA SHINY62011
Microcopy, Div. Neo-Flo, Inc.United StatesMakerGazelle · Minnow · NeoShine21989
Dentaurum GmbH & Co. KGGermanyMakerChamois leather polishing brush · Cloth polishing brush——
Debo Medical Technology (Shijiazhuang) Co., Ltd.ChinaMakerPOLISHING AGENT——
TDV Dental LtdaBrazilMakerFELT WHEELS · IMPREGNATED FELT WHEELS · POLIFIX · POLIMAX · +5——
Shanghai Alwings Medical Instrument Co.,Ltd.ChinaMakerDental Bur · Dental Cutter · Dental Drill · Dental Polishing Disc · +1——
Shanghai Jolly Industrial Co., Ltd.ChinaMakerPolishing strips——
Shanghai Lions Industrial Co., Ltd.ChinaMakerPolishing strips——
Tangshan Zhengtong Exhibition Co., Ltd.ChinaMaker———
DFS-Diamon GmbHGermanyMaker———
NTI Kahla GmbH Rotary Dental InstrumentsGermanyMakerCeraGlaze · DiaGloss · Goldstar · NTI · +5——
ZOGEAR Medical Co., Ltd.ChinaMakerPOLISHING AGENT——
Solventum US LLCUnited StatesMaker———
Anqing Clean Dental Instrument Technology Co LtdChinaMakerPolishing Kit IAC/WHEEL, POLISHING AGENT——
Cangzhou Lankang Medical Instruments Developing Co., Ltd.ChinaMakerDental polishing brush——
HuangHua DK Dental Co., LTD,ChinaMakerPolish wheel, strip, brush, cup, dish——
Henan Baistra Medical Devices LimitedChinaMakerWHEEL, POLISHING AGENT——
MDT Micro Diamond Technologies LtdIsraelMakerDaisy · Dental Rotary Instruments · Dental Rotary Polishers · MONOSTERYL · +1——
Gavin Biotechnology Co.,ltdChinaMakerDental Polishing Machine——
Edenta EtablissementLiechtensteinMakerPOLISHERS——
Creative China Creations LtdHong Kong SAR ChinaMakerPolishing Wheel——
Shanghai Toboom Dental Techology CO., LTD.ChinaMakerWHEEL, POLISHING AGENT——
Diaswiss, S. A.SwitzerlandMakerWHEEL, POLISHING AGENT——
Jota AGSwitzerlandMakerJOTA——
Foshan Fengyun Medical Technology Co., Ltd.ChinaMakerDental Polishing Bur——
Eve Ernst Vetter GmbHGermanyMakerEVE——
guangdong fuqiang beauty equipment co.,LimitedChinaMakerMetal polishing machine——
Zonefly Medical Devices Co., Ltd.ChinaMakerWHEEL, POLISHING AGENT——
Spectrum Plastics GroupUnited StatesMaker———
TVP Developments LtdHong Kong SAR ChinaMaker———
GC America Inc.United StatesContract manufacturerUltimate F&P Kit1372026
Zest Anchors, LLCUnited StatesManufacturer—262026
Sybron Dental SpecialtiesUnited StatesContract manufacturerCeraGlaze Spiral · DiaGloss Spiral · NTI SoftMat Wheel · Polishing Brushes · +12032026
Cosmedent, Inc.United StatesRepacker / relabelerFinishing Mandrels272024
Den-Mat Holdings, LLCUnited StatesManufacturerFinal Shine Cotton Polishing Wheels82026
Pac-Dent Inc.United StatesContract manufacturer—52022
Amann Girrbach AGAustriaForeign exporter—32026
Bicon, LLCUnited StatesManufacturerPolishing Kit IAC182015
ITENA ClinicalFrancePrivate-label distributorWHEEL, POLISHING AGENT82017
Sotera Health LLCUnited StatesContract manufacturer———
One DashcorpUnited StatesRepacker / relabelerValdent USA RA Mandrel, Contra-Angle——
Dentimed Sao Joao LLCUnited StatesRepacker / relabelerAngelus——
TitanLinks Logistics LLCUnited StatesRepacker / relabelerWHEEL, POLISHING AGENT——
Patterson Companies, Inc.United StatesForeign exporterPatterson Polishing Agent——
Summit Orthodontic Services, Inc.United StatesRepacker / relabelerHEATLESS WHEELS · Silent Stones——
Yizur LtdHong Kong SAR ChinaForeign exporterWHEEL, POLISHING AGENT——
Maxill Inc.United StatesForeign exporterMaxill——
Sanicure BVNetherlandsForeign exporter———
Zapalign LLCUnited StatesRepacker / relabeler———
Peter Brasseler Holdings, LLCUnited StatesContract manufacturer———
Opa Dental, LLCUnited StatesRepacker / relabelerCeramic grinder · Rubber polisher · Silicone polisher——
Oketz Logistics LLCUnited StatesRepacker / relabeler———

510(k) clearances

Decided510(k)DeviceApplicant
20 Dec 1978K781777ABRASIVE WHEELSDentsply Intl., Inc.

Official records: FDA product classification for EJQ · 21 CFR 872.6010.

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