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
3985–4008 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Nov 24, 2009
HG III FIXTURE SYSTEM
K093352 · DZE
Hiossen, Inc.
Dental · 28d
Cleared Nov 23, 2009
MULTIPLE (APEX LOCATOR), MODEL RCM-7
K090925 · LQY
J. Morita USA, Inc.
Dental · 235d
Cleared Nov 20, 2009
COSMEDENT BRUSHABLE COMPOSITE
K092730 · EBF
Cosmedent, Inc.
Dental · 77d
Cleared Nov 12, 2009
LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL
K092501 · EBF
Novocol, Inc.
Dental · 90d
Cleared Nov 10, 2009
STERNGOLD 2.2MM ANGLES MICRO ERA DENTAL IMPLANT SYSTEM
K092434 · DZE
Sterngold
Dental · 95d
Cleared Nov 04, 2009
LIQUICORD
K092384 · MVL
Centrix, Inc.
Dental · 91d
Cleared Nov 03, 2009
PLASTIC TEMPORARY ABUTMENTS, MODELS: PT341S, PT344S, PT341A, PT344A, PT451S,...
K092377 · NHA
Zimmer Dental, Inc.
Dental · 90d
Cleared Nov 03, 2009
INTRA LUX HEAD 3 LDSY
K092446 · EFA
Kaltenbach & Voigt GmbH & Co.
Dental · 85d
Cleared Nov 02, 2009
KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XX
K091192 · NPL
Kensey Nash Corp.
Dental · 193d
Cleared Oct 30, 2009
BUILD-IT LIGHT CURE
K091512 · EBF
Pentron Clinical Technologies
Dental · 162d
Cleared Oct 30, 2009
HI TECH IMPLANT, HT PHYSIO IMPLANT
K091913 · EKX
By Dental Srl
Dental · 122d
Cleared Oct 30, 2009
BIODENTINE
K092251 · KIF
Septodont
Dental · 94d
Cleared Oct 30, 2009
TI PREPABLE ABUTMENT, MODEL 1618, 1619, 1620
K092403 · NHA
Zimmer Dental, Inc.
Dental · 85d
Cleared Oct 30, 2009
PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II
K093221 · DYH
Dentsply Intl., Inc.
Dental · 17d
Cleared Oct 27, 2009
LOW & HIGH SPEED KIT
K090055 · EFA
Dpm USA Corp.
Dental · 292d
Cleared Oct 27, 2009
CLEARFIL MAJESTY POSTERIOR PLT
K092281 · EBF
Kuraray Medical, Inc.
Dental · 90d
Cleared Oct 23, 2009
ORTHOCAD IQ
K082207 · DYW
Cadent, Inc.
Dental · 444d
Cleared Oct 22, 2009
ZIROX
K092630 · EIH
Zencera, Inc.
Dental · 56d
Cleared Oct 21, 2009
ASCENT BOND UNIVERSAL ADHESIVE SYSTEM, MODELS 006-00029, 006-00030,...
K092616 · KLE
CAO Group, Inc.
Dental · 56d
Cleared Oct 20, 2009
EMS AIR-FLOW HANDY PERIO
K092289 · EFB
E.M.S Electro Medical Systems S.A
Dental · 83d
Cleared Oct 16, 2009
AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4
K091065 · EFB
J. Morita USA, Inc.
Dental · 185d
Cleared Oct 16, 2009
NOBEL/PROCERA IMPLANT BRIDGE
K091848 · NHA
Nobel Biocare AB
Dental · 116d
Cleared Oct 15, 2009
BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION
K092035 · DZE
Bicon, LLC
Dental · 101d
Cleared Oct 14, 2009
GRIND GUARD
K090472 · MQC
Archtek, Inc.
Dental · 232d