Product Code: EJR FDA class 1 21 CFR 872.6030

Agent, Polishing, Abrasive, Oral Cavity

Dental

The Oral Cavity Abrasive Polishing Agent is a dental material applied during prophylaxis appointments to remove plaque, stain, and pellicle from tooth surfaces using a mildly abrasive paste or powder preparation delivered via prophylaxis cup or brush. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EJR, regulated under 21 CFR 872.6030 in the Dental (DE) specialty.

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510(k)s

FEI Numbers

142

Registration Numbers

142

Unique Applicants

Years Active

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Basic Information

Product Code: EJR
Device Class: FDA class 1
Regulation Number: 872.6030
Medical Specialty: Dental
Review Panel: DE
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 77 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K171189	AIR-FLOW PLUS Prophylaxis powder	Sep 11, 2017	Substantially Equivalent	E.M.S Electro Medical Systems S.A
K131760	WHIP MIX PREPPIES PLUS	Mar 26, 2014	Substantially Equivalent	Whip-Mix Corp.
K121698	NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN	Aug 06, 2012	Substantially Equivalent	Dentsply International, Inc.
K103114	OSSPRAY SYLC CR	Mar 14, 2011	Substantially Equivalent	Osspray, Ltd.
K102053	BUTLER CALCI-FLOR PROPHYLAXIS PASTE	Feb 03, 2011	Substantially Equivalent	Sunstar Americas, Inc.
K101104	REMIN PRO	Oct 21, 2010	Substantially Equivalent	Voco GmbH
K100539	PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE	Jun 17, 2010	Substantially Equivalent	Preventive Technologies, Inc.
K070854	GC MI PASTE PLUS	Apr 12, 2007	Substantially Equivalent	GC America, Inc.
K062502	OSSPRAY CLEANING COMPOUND	Dec 15, 2006	Substantially Equivalent	Ospray, Ltd.
K062166	ENAMEL PRO	Nov 21, 2006	Substantially Equivalent	Premier Dental Products Co.
K042048	GELATO PROPHYLAXIS PASTE	Oct 26, 2004	Substantially Equivalent	Deepak Products, Inc.
K042200	MI PASTE	Oct 20, 2004	Substantially Equivalent	GC America, Inc.
K041371	BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN	Aug 23, 2004	Substantially Equivalent	Novamin Technology, Inc.
K040988	ZIRCON-F PROPHYLAXIS PASTE	Jul 07, 2004	Substantially Equivalent	Pascal Co., Inc.
K033785	PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE	Jun 18, 2004	Substantially Equivalent	Discus Dental, Inc.
K040661	RADENT PROPHY PASTE	Jun 09, 2004	Substantially Equivalent	Pascal Co., Inc.
K033449	PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES	Jan 07, 2004	Substantially Equivalent	Professional Dental Technologies Therapeutics, Inc.
K024343	BUTLER GUM PROPHY PASTE WITH NOVAMIN	Jul 11, 2003	Substantially Equivalent	Usbiomaterials Corp.
K002989	PROCLUDE	Dec 14, 2000	Substantially Equivalent	Ortek Therapeutics, Inc.
K000169	NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN	Mar 24, 2000	Substantially Equivalent	Dentsply Intl.
K990482	3M CLINPRO PROPHY PASTE, MODEL 12611	May 13, 1999	Substantially Equivalent	Minnesota Mining and Mfg. Co.
K973289	RE NU	Feb 09, 1999	Substantially Equivalent	Pacific Rim Dental, Inc.
K983966	NUPRO PROPHYLAXIS PASTE WITH FLOURIDE AND TRICLOSAN	Jan 29, 1999	Substantially Equivalent	Dentsply Intl.
K962370	PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE	Mar 31, 1997	Substantially Equivalent	Challenge Products, Inc.
K944575	AQUAFRESH PLAQUE FIGHTING GUM	Dec 15, 1994	Substantially Equivalent	Smithkline Beecham Consumer Healthcare Products
K942851	SMILE INTEGRATED PROPHYLAXIS PASTE RINGS	Nov 04, 1994	Substantially Equivalent	Germiphene Corp.
K940496	PROPHY PASTE	Apr 19, 1994	Substantially Equivalent	Challenge Products, Inc.
K935925	VISION PROPHY PASTE WITH FLUORIDE	Jan 26, 1994	Substantially Equivalent	Block Drug Company, Inc.
K933893	VISION PROPHY PASTE WITHOUT FLUORIDE	Nov 16, 1993	Substantially Equivalent	Block Drug Company, Inc.
K923675	DENSPRO MEDIUM MINT PROPHY PASTE	Nov 05, 1992	Substantially Equivalent	Teledyne Getz
K923674	DENSPRO COARSE MINT PROPHY PASTE	Nov 05, 1992	Substantially Equivalent	Teledyne Getz
K923020	CLEANIC	Sep 09, 1992	Substantially Equivalent	Hawe Neos Dental
K912945	SATIN PROPHYLAXIS PASTE	Sep 16, 1991	Substantially Equivalent	Dentsply Intl.
K905303	ABUTMENT GLO	Jun 10, 1991	Substantially Equivalent	Implant Innovations International, Inc.
K911284	PULPDENT DIAMOND POLISH	May 30, 1991	Substantially Equivalent	Pulpdent Corp.
K903986	SWIRL PROPHYLAXIS PASTE	Mar 28, 1991	Substantially Equivalent	Bio-Medica Concepts
K904199	HORIZON REGULAR ETCHING GEL	Dec 05, 1990	Substantially Equivalent	Horizon Chemical Co.
K901580	PROPHY PASTE	Sep 06, 1990	Substantially Equivalent	Dentsply Intl.
K903003	MPS DIAMOND POLISHING GEL	Aug 29, 1990	Substantially Equivalent	Abrasive Technology, Inc.
K896071	ULTRA II PORCELAIN POLISHING PASTE	Aug 14, 1990	Substantially Equivalent	Shofu Dental Corp.
K901873	DEGUFILL (R) POLISHING GEL	Aug 13, 1990	Substantially Equivalent	Degussa AG
K901973	CP-3 DENTAL POLISHING MATERIAL	Jun 01, 1990	Substantially Equivalent	Gresco Products, Inc.
K901052	PULPDENT OIL FREE SURFACE PREPARATION PASTE	Apr 16, 1990	Substantially Equivalent	Pulpdent Corp.
K896661	KEN'S PROPHY GEL - REGULAR	Feb 14, 1990	Substantially Equivalent	Pulpdent Corp.
K894933	PERLIDENT	Oct 12, 1989	Substantially Equivalent	Germiphene Corp.
K891536	ENAMEL MICROABRASION COMPOUND	Jun 09, 1989	Substantially Equivalent	Premier Dental Products Co.
K875339	JETPOLISHER AIRPOLISHING POWDER	Apr 18, 1988	Substantially Equivalent	Young Dental Manufacturing Co. 1, LLC
K873686	DIAMOND-LUSTER DENTAL POLISHING PASTE	Nov 12, 1987	Substantially Equivalent	Scientific Pharmaceuticals, Inc.
K872251	ABRASIVE DISC - POLISHING WHEEL	Jul 02, 1987	Substantially Equivalent	Dentsply Intl.
K864226	JOHNSON & JOHNSON STAINING REMOVING COMPOUND	May 01, 1987	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K865082	PROPHY CARE SOLUTION	Feb 12, 1987	Substantially Equivalent	Imd, Inc.
K864215	PROPHY CARE SOLUTION	Nov 18, 1986	Substantially Equivalent	Imd, Inc.
K863133	PROPHY CARE PASTE	Sep 25, 1986	Substantially Equivalent	Imd, Inc.
K862912	RENAMELIZE POLISHING PASTE	Aug 12, 1986	Substantially Equivalent	Cosmedent, Inc.
K860843	CHECK-UP PLAQUE FIGHTING GUM	May 21, 1986	Substantially Equivalent	Minnetonka, Inc.
K854828	SCI-PRO, PROPHYLAXIS PASTE	Mar 26, 1986	Substantially Equivalent	Scientific Pharmaceuticals, Inc.
K854829	DENSCO PROPHY PASTE	Mar 25, 1986	Substantially Equivalent	Scientific Pharmaceuticals, Inc.
K854588	INSTA-GLAZE	Feb 04, 1986	Substantially Equivalent	George Taub Products & Fusion Co., Inc.
K852814	GLOSSY POLISHING PASTE	Jul 31, 1985	Substantially Equivalent	Scientific Pharmaceuticals, Inc.
K851073	CUPRIDENT	Jul 31, 1985	Substantially Equivalent	Bio Systems, Inc.
K852157	TEMREX DENTAL POLISHING PASTE	Jul 19, 1985	Substantially Equivalent	Scientific Pharmaceuticals, Inc.
K852489	PROPOL DENTAL POLISHING PASTE	Jul 01, 1985	Substantially Equivalent	Scientific Pharmaceuticals, Inc.
K843022	KERR COMMAND ULTRAFINE POLISHING PASTE	Aug 24, 1984	Substantially Equivalent	Kerr Corporation (Danbury)
K842403	LUSTER, DENTAL POLISHING PASTE	Aug 17, 1984	Substantially Equivalent	Scientific Pharmaceuticals, Inc.
K840254	DIAMOND LUSTRE	Apr 25, 1984	Substantially Equivalent	Jelrus Technical Products Corp.
K822894	DIABRITE	Oct 18, 1982	Substantially Equivalent	Antraco, Inc.
K822142	DIAGLAZE	Sep 14, 1982	Substantially Equivalent	Antraco, Inc.
K812118	NIMETIC POLISHING PASTE	Aug 31, 1981	Substantially Equivalent	Espe-Premier Sales Co.
K810912	ALLOY COMPOSITE POLISH	Apr 23, 1981	Substantially Equivalent	Moyco Industries, Inc.
K810037	DENTAL CHEWING GUM (SUGARLESS)	Apr 08, 1981	Substantially Equivalent	Mcdennan Oral Products, Inc.
K801225	DEN-MAT POLISHING PASTE	Jun 17, 1980	Substantially Equivalent	Den-Mat Corp.
K791319	MIRADAPT* POLISHING INSTRUMENTS	Sep 12, 1979	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K780834	PREVI DENT PROPHYLAXIS MINT NDC	Jun 02, 1978	Substantially Equivalent	Hoyt Laboratories
K771852	NIMETIC POLISHING PASTE	Nov 02, 1977	Substantially Equivalent	Espe GmbH (Us)
K771401	PROPHY PASTE	Aug 22, 1977	Substantially Equivalent	L.D. Caulk Co.
K760658	DETARTRINE P	Sep 27, 1976	Substantially Equivalent	Septodont, Inc.
K760656	DETARTRINE Z	Sep 27, 1976	Substantially Equivalent	Mr. J. Garrick Eisenberg