FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Dental ×
12,577 results
11905–11928 of 12,577
Search insights Median review: 86d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jul 28, 1981
KULZER TRANSLUX VISIBLE LIGHT CURING
K811668 · EBZ
Kulzer, Inc.
Dental · 43d
Cleared Jul 28, 1981
SE WON(ALUMINUM) DENTAL FLOSS HOLDER
K811926 · JES
Sewon Industry
Dental · 22d
Cleared Jul 24, 1981
R & S SERIES FITTING TOOLS
K811889 · EIC
Suncoast Dental Corp.
Dental · 23d
Cleared Jul 24, 1981
R & S SERIES IMPLANTS
K811923 · DZE
Suncoast Dental Corp.
Dental · 22d
Cleared Jul 23, 1981
BASE METAL ALLOY
K811258 · EJH
Dentsply Intl.
Dental · 79d
Cleared Jul 15, 1981
WATER PISTOL
K811594 · EIC
Aus-Tex Dental Mfg. & Design
Dental · 37d
Cleared Jul 15, 1981
SR-ISOCETTE
K811665 · ELK
J. Aderer, Inc.
Dental · 30d
Cleared Jul 15, 1981
COLTENE COLTEX/COLTOFLAX
K811666 · ELW
Coltene, Inc.
Dental · 30d
Cleared Jul 15, 1981
COLTENE PRESSURE SPOT INDICATOR
K811667 · ELW
Coltene, Inc.
Dental · 30d
Cleared Jul 15, 1981
COLTENE PRESIDENT IMPRESSION MATERIALS
K811767 · ELW
Coltene, Inc.
Dental · 23d
Cleared Jul 01, 1981
DENTAL FLOSS HOLDER
K811555 · JES
Sewon Industry
Dental · 29d
Cleared Jul 01, 1981
DURAFILL MICROFILL RESTORATIVE MATERIAL
K811669 · EBF
Kulzer, Inc.
Dental · 16d
Cleared Jun 26, 1981
SUMMAR NON-PRECIOUS, CERAMIC ALLOY
K811013 · EJH
Shofu Dental Corp.
Dental · 72d
Cleared Jun 26, 1981
SONUS V
K811396 · ELC
California Technics, Inc.
Dental · 39d
Cleared Jun 26, 1981
K-FLEX
K811519
Sybron Corp.
Dental · 29d
Cleared Jun 26, 1981
FUJI IONOMER TYPE I & II
K811521 · EMA
G-C Intl. Corp.
Dental · 28d
Cleared Jun 26, 1981
VISIO-SEAL
K811624 · EBC
Espe-Premier Sales Co.
Dental · 17d
Cleared Jun 16, 1981
RIESS-LUHR
K811113 · DZA
Allomedic
Dental · 54d
Cleared Jun 16, 1981
PNEUMATIC DENTAL SCALER
K811145 · ELC
Innovate, Inc.
Dental · 50d
Cleared Jun 16, 1981
JACOB WIRZ TRANSFIXATION PIN
K811209 · ELS
Colmed, Ltd.
Dental · 46d
Cleared Jun 16, 1981
MAGNETIC RETENTION UNIT
K811237 · ECG
Universiti Malaya
Dental · 43d
Cleared Jun 16, 1981
COLTENE DRS DENTAL RESTORATIVE SYSTEM
K811363 · EBF
Coltene, Inc.
Dental · 33d
Cleared Jun 16, 1981
BA-93
K811407 · EJH
Deringer-Ney, Inc.
Dental · 28d
Cleared Jun 16, 1981
ENHANCE DENTAL RESTORATIVE
K811443 · EBF
Johnson & Johnson Professionals, Inc.
Dental · 25d