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
7177–7200 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jun 11, 1998
3M M.G. MATERIAL
K981325 · ELW
3M Company
Dental · 59d
Cleared Jun 11, 1998
ODONTOSURGE 2
K981390 · EKZ
Periogiene
Dental · 56d
Cleared Jun 09, 1998
LONE STAR IMPRESSION SYSTEMS
K980968 · ELW
Lone Star Technologies
Dental · 85d
Cleared Jun 09, 1998
THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
K980983 · JEY
Biomedics
Dental · 84d
Cleared Jun 05, 1998
PROVI CEMENT
K973201 · EMA
S & C Polymer GmbH
Dental · 283d
Cleared Jun 05, 1998
MACH-SIGMA HANDPIECE, ULTRAPUSH
K980162 · EFB
Nsk Nakanishi, Inc.
Dental · 140d
Cleared Jun 05, 1998
LACTOSORB PANELS AND FASTENERS
K980927 · JEY
Biomet, Inc.
Dental · 86d
Cleared Jun 05, 1998
FLARE,FILE, FILL
K981234 · EJB
Lone Star Technologies
Dental · 62d
Cleared Jun 01, 1998
ICON IMPLANT SYSTEM
K974106 · DZE
Bio Science Technologies, Inc.
Dental · 213d
Cleared Jun 01, 1998
SNORE-CURE ANTI-SNORING APPLIANCE
K980952 · LRK
Ortho-Tain, Inc.
Dental · 80d
Cleared Jun 01, 1998
MIRACLE MIX CAPSULE
K981370 · EMA
GC America, Inc.
Dental · 47d
Cleared May 26, 1998
BRANEMARK SYSTEM DEC 600 DRILLING UNIT
K974123 · DZE
Nobel Biocare Uas, Inc.
Dental · 204d
Cleared May 26, 1998
AIRPREP SYSTEM - MODEL 9001
K974488 · KOJ
Asi Medical, Inc.
Dental · 181d
Cleared May 21, 1998
NEOCOLLOID, ORTHOPRINT
K981091 · ELW
Zhermack S.P.A.
Dental · 57d
Cleared May 20, 1998
COPPER TONGUE SCRAPER
K980842 · LCN
Ontel Products Corp.
Dental · 77d
Cleared May 20, 1998
20-HOLE ADAPTATION PLATE
K981070 · JEY
Biomet, Inc.
Dental · 57d
Cleared May 19, 1998
CRISTOBAL
K980018 · EBF
Newave Medical, Inc.
Dental · 137d
Cleared May 18, 1998
ORION VESTA DENTAL ALLOY
K981001 · EJS
European Dental Imports, Inc.
Dental · 61d
Cleared May 18, 1998
ORION WX DENTAL ALLOY
K981002 · EJS
European Dental Imports, Inc.
Dental · 61d
Cleared May 15, 1998
DENTATUS MTI MODULAR TRANSITIONAL IMPLANTS AND PROSTHETIC SYSTEM
K980620 · DZE
Dentatus USA , Ltd.
Dental · 86d
Cleared May 15, 1998
CU-100A LIGHT CURE UNIT
K980792 · EBF
Rolence Enterprise Co. , Ltd.
Dental · 74d
Cleared May 15, 1998
Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNIT
K980793 · EBF
Rolence Enterprise Co. , Ltd.
Dental · 74d
Cleared May 15, 1998
CARRARA PORCELAIN AND CARRARA VINCENT PORCELAIN
K981000 · EIH
European Dental Imports, Inc.
Dental · 58d
Cleared May 12, 1998
ULTRA-BLASTER
K980726 · KOJ
Ultradent Products, Inc.
Dental · 77d