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 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 Nov 21, 2006
ENAMEL PRO
K062166
Premier Dental Products Co.
Dental · 116d
Cleared Oct 20, 2004
MI PASTE
K042200
GC America, Inc.
Dental · 68d
Cleared Mar 24, 2000
NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN
K000169
Dentsply Intl.
Dental · 64d
Cleared Jan 29, 1999
NUPRO PROPHYLAXIS PASTE WITH FLOURIDE AND TRICLOSAN
K983966
Dentsply Intl.
Dental · 84d
Cleared Sep 16, 1991
SATIN PROPHYLAXIS PASTE
K912945
Dentsply Intl.
Dental · 73d
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
Cleared Nov 12, 1987
DIAMOND-LUSTER DENTAL POLISHING PASTE
K873686
Scientific Pharmaceuticals, Inc.
Dental · 59d
Cleared Jul 02, 1987
ABRASIVE DISC - POLISHING WHEEL
K872251
Dentsply Intl.
Dental · 20d
Cleared May 01, 1987
JOHNSON & JOHNSON STAINING REMOVING COMPOUND
K864226
Johnson & Johnson Professionals, Inc.
Dental · 185d
Cleared Mar 26, 1986
SCI-PRO, PROPHYLAXIS PASTE
K854828
Scientific Pharmaceuticals, Inc.
Dental · 113d
Cleared Mar 25, 1986
DENSCO PROPHY PASTE
K854829
Scientific Pharmaceuticals, Inc.
Dental · 112d
Cleared Jul 31, 1985
GLOSSY POLISHING PASTE
K852814
Scientific Pharmaceuticals, Inc.
Dental · 29d
Cleared Jul 19, 1985
TEMREX DENTAL POLISHING PASTE
K852157
Scientific Pharmaceuticals, Inc.
Dental · 63d
Cleared Jul 01, 1985
PROPOL DENTAL POLISHING PASTE
K852489
Scientific Pharmaceuticals, Inc.
Dental · 24d
Cleared Aug 24, 1984
KERR COMMAND ULTRAFINE POLISHING PASTE
K843022
Kerr Corporation (Danbury)
Dental · 23d

About Product Code EJR - Regulatory Context