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
6361–6384 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared May 18, 2001
SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR
K010690 · DZL
Synthes (Usa)
Dental · 71d
Cleared May 17, 2001
CLASSIC CEM
K011064 · EMA
S & C Polymer GmbH
Dental · 41d
Cleared May 17, 2001
XSE
K011167 · KLE
3M Company
Dental · 31d
Cleared May 16, 2001
LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS
K002037 · DZE
Lifecore Biomedical, Inc.
Dental · 315d
Cleared May 16, 2001
ELIPAR FREELIGHT
K011154 · EBZ
Espe Dental AG
Dental · 30d
Cleared May 15, 2001
TAPER-LOCK DENTAL IMPLANT SYSTEM
K011038 · DZE
Sulzer Dental, Inc.
Dental · 40d
Cleared May 14, 2001
MODIFICATION TO THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
K011380 · JEY
Bioplate, Inc.
Dental · 7d
Cleared May 10, 2001
ITI DENTAL IMPLANT SYSTEM
K010291 · DZE
Straumann USA
Dental · 99d
Cleared May 10, 2001
THE MAESTRO SYSTEM
K010458 · DZE
BioHorizons Implant Systems, Inc.
Dental · 83d
Cleared May 10, 2001
DENTO-PREP PARTICLE MICROBLASTER
K010816 · KOJ
Ronvig A/S
Dental · 52d
Cleared May 10, 2001
RD-3008
K011036 · EJT
Heraeus Kulzer, Inc.
Dental · 35d
Cleared May 07, 2001
D/C CORE MATERIAL
K010475 · EBF
Parkell, Inc.
Dental · 76d
Cleared May 03, 2001
SYNTHES (USA) MIDFACE DISTRACTOR
K010499 · JEY
Synthes (Usa)
Dental · 71d
Cleared May 02, 2001
WHITE MTA MATERIAL
K011009 · KIF
Dentsply International
Dental · 28d
Cleared May 02, 2001
BIOUNIVERSAL PDF
K011022 · EJT
Ivoclar North America, Inc.
Dental · 28d
Cleared May 02, 2001
D.SIGN 96
K011023 · EJT
Ivoclar North America, Inc.
Dental · 28d
Cleared Apr 27, 2001
SENOJ IMPLANT SYSTEM
K000889 · DZE
Senoj Biocare, Inc.
Dental · 403d
Cleared Apr 25, 2001
SYNTHES (USA) IMF SCREWS
K010527 · DZL
Synthes (Usa)
Dental · 62d
Cleared Apr 23, 2001
TAKE ONE BITE MODIFIED
K010994 · ELW
Kerr Corp.
Dental · 20d
Cleared Apr 20, 2001
CAVITY VARNISH
K010255 · LBH
Rite-Dent Manufacturing Corp.
Dental · 81d
Cleared Apr 20, 2001
BEAUTIFIL
K010914 · EBF
Shofu Dental Corp.
Dental · 24d
Cleared Apr 17, 2001
PREMIER ULTRASONIC SCALER AND INSERTS
K010195 · ELC
Premier Dental Products Co.
Dental · 85d
Cleared Apr 17, 2001
Y-TZP POWDER AND PROCERA ALLZIRKON
K010630 · EIH
Procera Sandvik, Inc.
Dental · 46d
Cleared Apr 13, 2001
3M ESPE HAUR
K010781 · EBF
3M Company
Dental · 29d