Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

41 results for "Premier Dental Products Co."
1–24 of 41
Search insights Median review: 76d Cleared: 100% Top manufacturer: Premier Dental Products Co. Lead specialty: Dental
Cleared Nov 17, 2014
PREMIER ETCH
K141839 · KLE
Premier Dental Products Co.
Dental · 132d
Cleared Nov 26, 2013
KNIT-PAK+
K132526 · MVL
Premier Dental Products Co.
Dental · 106d
Cleared Aug 26, 2013
PREMIER CERAMIC PRIMER
K131212 · KLE
Premier Dental Products Co.
Dental · 119d
Cleared Apr 28, 2009
TRAXODENT
K083695 · MVL
Premier Dental Products Co.
Dental · 134d
Cleared Nov 21, 2006
ENAMEL PRO VARNISH
K062683 · LBH
Premier Dental Products Co.
Dental · 74d
Cleared Nov 21, 2006
ENAMEL PRO
K062166 · EJR
Premier Dental Products Co.
Dental · 116d
Cleared Oct 04, 2006
PREMIER SELF-ETCHING BOND ENHANCER
K061998 · KLE
Premier Dental Products Co.
Dental · 82d
Cleared Oct 04, 2006
PREMIER SELF-ETCHING ENAMEL SEALANT
K061997 · EBC
Premier Dental Products Co.
Dental · 82d
Cleared Sep 06, 2005
PREMIER TEMPORARY CEMENT
K051866 · EMA
Premier Dental Products Co.
Dental · 57d
Cleared Sep 21, 2004
RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT
K042215 · EMA
Premier Dental Products Co.
Dental · 36d
Cleared Jan 26, 2004
PREMIER IMPLANT CEMENT, MODEL 3001450
K033309 · EMA
Premier Dental Products Co.
Dental · 104d
Cleared Sep 27, 2001
COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408
K012160 · EBF
Premier Dental Products Co.
Dental · 78d
Cleared Apr 17, 2001
PREMIER ULTRASONIC SCALER AND INSERTS
K010195 · ELC
Premier Dental Products Co.
Dental · 85d
Cleared Jun 17, 1997
PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS
K970992 · GEH
Premier Dental Products Co.
General & Plastic Surgery · 90d
Cleared Apr 05, 1995
PREMIER PROMAX BITE GUARD
K941856 · JXL
Premier Dental Products Co.
Neurology · 355d
Cleared Jan 18, 1995
PREMIER MIRROR WARMER
K945395 · ETF
Premier Dental Products Co.
Ear, Nose, Throat · 76d
Cleared Oct 13, 1992
ELECTROSURGICAL ELECTRODES
K923332 · GEI
Premier Dental Products Co.
General & Plastic Surgery · 98d
Cleared Jun 24, 1991
HARDCOATED PLASTIC FILLING INSTRUMENT
K912149 · EKJ
Premier Dental Products Co.
Dental · 40d
Cleared Jun 09, 1989
ENAMEL MICROABRASION COMPOUND
K891536 · EJR
Premier Dental Products Co.
Dental · 84d
Cleared Oct 12, 1984
INTRAUTERINE DEVICE REMOVER
K842295 · HHF
Premier Dental Products Co.
Obstetrics & Gynecology · 123d
Cleared Jun 15, 1984
ELEVATOR - VARIOUS
K841011 · EMS
Premier Dental Products Co.
Dental · 98d
Cleared Jun 08, 1984
BIOPSY PUNCH, VARIOUS
K841008 · GEE
Premier Dental Products Co.
General & Plastic Surgery · 91d
Cleared May 30, 1984
EAR KNIFE-VARIOUS
K841006 · JYO
Premier Dental Products Co.
Ear, Nose, Throat · 82d
Cleared May 30, 1984
TONSIL KNIFE-VARIOUS
K841005 · KBQ
Premier Dental Products Co.
Ear, Nose, Throat · 82d