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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Dental ×
12,611 results
10153–10176 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jan 22, 1990
SAFE-T-CAP NEEDLE COVER
K896219 · DZM
Ausmedics Pty , Ltd.
Dental · 87d
Cleared Jan 19, 1990
ANEST-EZE DENTAL DRILL RA#2
K896149 · DZA
Signature One Products, Inc.
Dental · 88d
Cleared Jan 16, 1990
BASIC CALCIUM HYDROXIDE LINER
K896529 · EJK
Ivoclar North America, Inc.
Dental · 63d
Cleared Jan 10, 1990
DENTAL ENDODONTIC CEMENT (MODIFICATION)
K894092 · KIF
The Hygenic Corp.
Dental · 216d
Cleared Jan 10, 1990
INSURE MATCH MATE PORCELAIN VENEER TRY-IN SYSTEM
K894477 · EMA
Cosmedent, Inc.
Dental · 176d
Cleared Jan 10, 1990
SANI-PIKS DENTAL HAND INSTRUMENT
K895985 · EKJ
Bison-Lee Co.
Dental · 89d
Cleared Jan 10, 1990
ENAMEL PREP ENAMEL ETCHANT (EMAIL-PREPARATOR GS)
K896132 · EBF
Ivoclar North America, Inc.
Dental · 79d
Cleared Jan 09, 1990
RATE INCREASE FOR IPPB/IPV
K896586 · DZD
Percussionaire Corp.
Dental · 48d
Cleared Dec 26, 1989
RAMVAC DENTAL VACUUM SYSTEM
K895876 · EIA
Ramvac Corp.
Dental · 82d
Cleared Dec 26, 1989
RAMCLEAN DENTAL VACUUM LINE CLEANER
K895877 · EIA
Ramvac Corp.
Dental · 82d
Cleared Dec 22, 1989
FIRST IMPRESSION TM
K894282 · ELW
Coe Laboratories, Inc.
Dental · 182d
Cleared Dec 22, 1989
TOOTH SHADE RESIN
K895976 · EBF
G-C Intl. Corp.
Dental · 71d
Cleared Dec 21, 1989
ARTECH TYPE SS SUBMERGED SCREW IMPLANT
K891346 · DZE
Artech Corp.
Dental · 286d
Cleared Dec 21, 1989
ISODENT
K894058 · EIA
Eurodent, Inc.
Dental · 197d
Cleared Dec 21, 1989
ORTHO-KEV APPLIANCE REINFORCING SYSTEM
K895714 · EBI
American Orthodontics
Dental · 87d
Cleared Dec 21, 1989
HEMA-PRIMER
K895750 · KLE
Parkell
Dental · 86d
Cleared Dec 21, 1989
SILCOT COPAL CAVITY VARNISH
K895798 · EMA
Specialites Septodont
Dental · 84d
Cleared Dec 20, 1989
SEQUEL (CASTING ALLOY FOR PORCELAIN-FUSED-METAL)
K893800 · EJT
Deringer-Ney, Inc.
Dental · 212d
Cleared Dec 20, 1989
TALLADIUM TILITE CERAMIC ALLOY
K894085 · EJH
Talladium, Inc.
Dental · 195d
Cleared Dec 20, 1989
PLASTIC TOOTH REINFORCEMENT KIT
K895758 · EBL
Nanzee Dental Products
Dental · 85d
Cleared Dec 19, 1989
.650 FINE GOLD SOLDER
K895054 · EJT
Leach and Dillon Co., Inc.
Dental · 133d
Cleared Dec 19, 1989
LOW FUSING WHITE GOLD
K895056 · EJT
Leach and Dillon Co., Inc.
Dental · 133d
Cleared Dec 19, 1989
750 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS
K895060 · EJT
Leach and Dillon Co., Inc.
Dental · 133d
Cleared Dec 19, 1989
450 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS
K895063 · EJT
Leach and Dillon Co., Inc.
Dental · 133d