EJR · Class I · 21 CFR 872.6030

FDA Product Code EJR: Agent, Polishing, Abrasive, Oral Cavity

Leading manufacturers include Scientific Pharmaceuticals, Inc., Dentsply Intl. and Pulpdent Corp..

77
Total
77
Cleared
96d
Avg days
1976
Since

FDA 510(k) Cleared Agent, Polishing, Abrasive, Oral Cavity Devices (Product Code EJR)

77 devices
1–24 of 77
Cleared Sep 11, 2017
AIR-FLOW PLUS Prophylaxis powder
K171189
E.M.S Electro Medical Systems S.A
Dental · 140d
Cleared Mar 26, 2014
WHIP MIX PREPPIES PLUS
K131760
Whip-Mix Corp.
Dental · 282d
Cleared Aug 06, 2012
NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN
K121698
Dentsply International, Inc.
Dental · 59d
Cleared Oct 21, 2010
REMIN PRO
K101104
Voco GmbH
Dental · 184d
Cleared Apr 12, 2007
GC MI PASTE PLUS
K070854
GC America, Inc.
Dental · 15d
Cleared Dec 15, 2006
OSSPRAY CLEANING COMPOUND
K062502
Ospray, Ltd.
Dental · 112d
Cleared Nov 21, 2006
ENAMEL PRO
K062166
Premier Dental Products Co.
Dental · 116d
Cleared Oct 26, 2004
GELATO PROPHYLAXIS PASTE
K042048
Deepak Products, Inc.
Dental · 88d
Cleared Oct 20, 2004
MI PASTE
K042200
GC America, Inc.
Dental · 68d
Cleared Aug 23, 2004
BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN
K041371
Novamin Technology, Inc.
Dental · 91d
Cleared Mar 24, 2000
NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN
K000169
Dentsply Intl.
Dental · 64d
Cleared May 13, 1999
3M CLINPRO PROPHY PASTE, MODEL 12611
K990482
Minnesota Mining and Mfg. Co.
Dental · 86d
Cleared Feb 09, 1999
RE NU
K973289
Pacific Rim Dental, Inc.
Dental · 525d
Cleared Jan 29, 1999
NUPRO PROPHYLAXIS PASTE WITH FLOURIDE AND TRICLOSAN
K983966
Dentsply Intl.
Dental · 84d
Cleared Mar 31, 1997
PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE
K962370
Challenge Products, Inc.
Dental · 285d
Cleared Sep 16, 1991
SATIN PROPHYLAXIS PASTE
K912945
Dentsply Intl.
Dental · 73d
Cleared Jun 10, 1991
ABUTMENT GLO
K905303
Implant Innovations International, Inc.
Dental · 194d
Cleared May 30, 1991
PULPDENT DIAMOND POLISH
K911284
Pulpdent Corp.
Dental · 90d
Cleared Sep 06, 1990
PROPHY PASTE
K901580
Dentsply Intl.
Dental · 155d
Cleared Aug 14, 1990
ULTRA II PORCELAIN POLISHING PASTE
K896071
Shofu Dental Corp.
Dental · 299d
Cleared Aug 13, 1990
DEGUFILL (R) POLISHING GEL
K901873
Degussa AG
Dental · 111d
Cleared Apr 16, 1990
PULPDENT OIL FREE SURFACE PREPARATION PASTE
K901052
Pulpdent Corp.
Dental · 42d
Cleared Feb 14, 1990
KEN'S PROPHY GEL - REGULAR
K896661
Pulpdent Corp.
Dental · 82d
Cleared Jun 09, 1989
ENAMEL MICROABRASION COMPOUND
K891536
Premier Dental Products Co.
Dental · 84d

About Product Code EJR - Regulatory Context