FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Dental ×
12,637 results
12145–12168 of 12,637
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jul 08, 1980
CROWN DELTA SILICONE IMPRESSION MATERIAL
K801380 · ELW
Crown Delta Corp.
Dental · 27d
Cleared Jun 20, 1980
REIGNING ARTIFICIAL TEETH/POLYCARB.RESIN
K801235 · ELM
Oki Shiks USA , Ltd.
Dental · 24d
Cleared Jun 17, 1980
DEN-MAT POLISHING PASTE
K801225 · EJR
Den-Mat Corp.
Dental · 26d
Cleared Jun 09, 1980
REIGNING DENTURE MADE OF POLYCARB. RESIN
K801234 · EBI
Oki Shiks USA , Ltd.
Dental · 13d
Cleared Jun 09, 1980
REIGNING CROWN-BRIDGE/POLYCARB. RESIN
K801237 · EBF
Oki Shiks USA , Ltd.
Dental · 13d
Cleared Jun 09, 1980
S.S. WHITE-PENNWALT PRELUDE PIT SEALANT
K801274 · EBC
Pennwalt Corp.
Dental · 11d
Cleared Jun 04, 1980
HOWMEDICA WHITE C&B ALLOY
K801009 · EJS
Dental Laboratory Products Div.
Dental · 37d
Cleared Jun 04, 1980
BONDALCAP (SILICO-PHOSPHATE)
K801228 · EMA
Vivadent (Usa), Inc.
Dental · 12d
Cleared Jun 04, 1980
BONDALCAP (CARBOXYLATE)
K801229 · EMA
Vivadent (Usa), Inc.
Dental · 12d
Cleared May 28, 1980
HOLLOW BASKET TITANIUM DENTAL IMPLANT
K801208 · ELE
Colmed, Ltd.
Dental · 8d
Cleared May 28, 1980
DEN-MAT DENTIN BONDING AGENT
K801216 · KLE
Den-Mat Corp.
Dental · 7d
Cleared May 20, 1980
VACUDENT LUMIX 65
K800574 · EHP
Vacudent Sales Corp.
Dental · 67d
Cleared May 20, 1980
VACUDENT LUMIX 70
K800575 · EHP
Vacudent Sales Corp.
Dental · 67d
Cleared May 20, 1980
PLY LESIVE
K801047 · LBH
May-Pell Chemical Development Co.
Dental · 15d
Cleared May 20, 1980
KWIX-BITE X-RAY FILM HOLDER
K801079 · EGZ
Henry Schein, Inc.
Dental · 13d
Cleared May 20, 1980
PRISMA-FILL
K801092 · EBF
Dentsply Intl.
Dental · 12d
Cleared May 20, 1980
PRISMA-BOND
K801093 · KLE
Dentsply Intl.
Dental · 12d
Cleared May 14, 1980
PS3 TITANIUM SCREW DENTAL IMPLANT
K800762 · DZE
Colmed, Ltd.
Dental · 37d
Cleared May 08, 1980
MYERSON R&KENSON R PORCELAIN ANT&POS.-
K800829 · ELL
Myerson Tooth Corp.
Dental · 24d
Cleared May 08, 1980
PY-CO-PROX TM DENTAL BRUSH
K800831 · EFW
Block Drug Company, Inc.
Dental · 24d
Cleared May 08, 1980
ORAVIEW BY WATER PIK
K800919 · EAX
Teledyne, Inc.
Dental · 17d
Cleared May 08, 1980
CASTA-LLOY
K800951 · EJS
U.S. Shizai Corp.
Dental · 15d
Cleared May 02, 1980
AUSTRY ALLOY(DENTAL BAKE-ON ALLOY)
K800994 · EJS
Howmedica Corp.
Dental · 7d
Cleared Apr 29, 1980
PREMIER ABSORBENT POINTS
K800827 · EKN
Premier Dental Products Co.
Dental · 15d