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
11977–12000 of 12,637
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
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
Cleared Jun 12, 1981
HY-BOND POLYCARBOXYLATE CEMENT
K810764 · EMA
Shofu Dental Corp.
Dental · 81d
Cleared Jun 12, 1981
HY-BOND ZINC PHOSPHATE CEMENT
K810765 · EMA
Shofu Dental Corp.
Dental · 81d
Cleared May 27, 1981
RECOH ROOT CANAL IRRIGATOR
K811175 · EFS
Koei International, Inc.
Dental · 29d
Cleared May 13, 1981
ENDODONTIC POST SYSTEMS
K810977 · ECG
Preat Corp.
Dental · 33d
Cleared May 13, 1981
BALANCE ARTICULATOR
K811075 · EJP
Almore Intl., Inc.
Dental · 23d
Cleared May 13, 1981
HOYT ECONO-TRAY
K811154 · KMT
Hoyt Laboratories
Dental · 15d
Cleared May 05, 1981
ISOSIT C & B MATERIAL
K810969 · EBF
Bauer, Cheng & Associates, Inc.
Dental · 26d
Cleared May 05, 1981
ISOSIT TEETH
K810970 · ELM
Bauer, Cheng & Associates, Inc.
Dental · 26d
Cleared May 05, 1981
THE GNATOMET
K810971 · EJP
Bauer, Cheng & Associates, Inc.
Dental · 26d
Cleared May 05, 1981
THE GNATHOMETER-M
K810972 · KZO
Bauer, Cheng & Associates, Inc.
Dental · 26d
Cleared May 05, 1981
REVERSIBLE HYDROCOLLOID IMPRESSION
K811020 · ELW
Kottler Laboratories
Dental · 20d
Cleared May 05, 1981
ROOT CANAL KIT
K811023 · ELC
Dentsply Intl.
Dental · 20d