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
7513–7536 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jun 04, 1997
STERILE SUREFLEX FILES AND INSTRUMENTS
K971603 · EFA
Dentsply Intl.
Dental · 34d
Cleared Jun 03, 1997
TEMPOCEM NE (MULTIPLE)
K970774 · EMA
Foremost Dental Mfg., Inc.
Dental · 91d
Cleared Jun 03, 1997
TEMPO CEM (MULTIPLE)
K970775 · EMA
Foremost Dental Mfg., Inc.
Dental · 91d
Cleared Jun 03, 1997
OPTIMA PLUS E DENTAL CHAIR
K971063 · KLC
King Dental Corp.
Dental · 71d
Cleared Jun 03, 1997
OPALDAM
K971284 · EIG
Ultradent Products, Inc.
Dental · 57d
Cleared Jun 03, 1997
COMPOGLASS F
K971513 · EBF
Ivoclar North America, Inc.
Dental · 36d
Cleared Jun 03, 1997
STERILE FLEXOFILE FILES AND INSTRUMENTS
K971606 · EFA
Dentsply Intl.
Dental · 33d
Cleared May 29, 1997
VARIOLINK II
K971372 · EBF
Ivoclar North America, Inc.
Dental · 45d
Cleared May 27, 1997
CYBERJET LOCAL ANESTHESIA SYSTEM
K964802 · EGM
Intra Vantage, Inc.
Dental · 179d
Cleared May 27, 1997
LIFECORE O-RING ABUTMENT
K970776 · DZE
Lifecore Biomedical, Inc.
Dental · 84d
Cleared May 23, 1997
ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR
K971100 · EIA
Atrion Medical Products, Inc.
Dental · 58d
Cleared May 22, 1997
AYURVEDIC TONGUE CLEANER
K971025 · LCN
Calello Martinez P.C.
Dental · 63d
Cleared May 22, 1997
MEMOREG
K971155 · ELW
Heraeus Kulzer, Inc.
Dental · 55d
Cleared May 22, 1997
NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES
K971319 · EKS
Tycom Dental
Dental · 42d
Cleared May 20, 1997
JEL-71 PDF
K971292 · EJT
J.F. Jelenko & Co., Inc.
Dental · 43d
Cleared May 20, 1997
JELBOND-PDF
K971574 · EJT
J.F. Jelenko & Co., Inc.
Dental · 43d
Cleared May 19, 1997
KWAN HEXAGONAL ABUTMENT IMPLANT SYSTEM (HAIS)
K962753 · DZE
Biomedical Implant Technology, Inc.
Dental · 308d
Cleared May 16, 1997
HERO 642
K970649 · EKS
Micro-Mega
Dental · 85d
Cleared May 14, 1997
ODYSSEY I DENTAL WATER UNIT
K964796 · EIA
Germiphene Corp.
Dental · 166d
Cleared May 14, 1997
MYERSON'S ECONOMY DENTURE BASE MATERIAL
K970522 · EBI
Austenal, Inc.
Dental · 92d
Cleared May 12, 1997
ODONT HEX SYSTEM
K961631 · DZE
Odontit S.A.
Dental · 378d
Cleared May 08, 1997
RESOLUT REGENERATIVE MATERIAL
K970884 · LYC
W.L. Gore & Associates, Inc.
Dental · 59d
Cleared May 08, 1997
ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM
K971196 · DZE
Innova Corp.
Dental · 38d
Cleared May 07, 1997
SIMPLEX AIRBRATOR
K970249 · KOJ
Simplex Medical Systems, Inc.
Dental · 105d