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
5713–5736 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jul 17, 2003
GLASIONOMER FX-II
K031467 · EMA
Shofu Dental Corp.
Dental · 70d
Cleared Jul 15, 2003
ESTYLUS ELECTRIC MOTOR SYSTEM
K031145 · EFB
Dentsply Intl.
Dental · 96d
Cleared Jul 15, 2003
SAFETY RELEASE ARCH BAR KIT
K031207 · DYX
Casey Surgical, LLC
Dental · 90d
Cleared Jul 11, 2003
BUTLER GUM PROPHY PASTE WITH NOVAMIN
K024343 · EJR
Usbiomaterials Corp.
Dental · 196d
Cleared Jul 11, 2003
TEMPORARY RESIN CEMENT
K031212 · EMA
Parkell, Inc.
Dental · 85d
Cleared Jul 09, 2003
PROPHYPEARLS
K031868 · EFB
Kavo America
Dental · 22d
Cleared Jul 08, 2003
THE SUAD DEVICE
K023836 · LRK
Strong Dental, Inc.
Dental · 232d
Cleared Jul 07, 2003
ITI DENTAL IMPLANT SYSTEM
K031055 · DZE
Straumann USA
Dental · 95d
Cleared Jul 03, 2003
CARBON FIBER BRIDGE, MODEL 28757
K031070 · EBI
Nobel Biocare AB
Dental · 90d
Cleared Jul 03, 2003
STAND OUT
K031484 · ELW
Kerr Corp.
Dental · 52d
Cleared Jul 02, 2003
OPTIBOND FL
K031444 · KLE
Kerr Dental Materials Center
Dental · 56d
Cleared Jul 02, 2003
FILL-IN
K031476 · EBG
Sybron Dental Specialties, Inc.
Dental · 54d
Cleared Jul 02, 2003
ESTHETIC ZIRCONIA ABUTMENT
K031719 · NHA
Nobel Biocare AB
Dental · 29d
Cleared Jul 02, 2003
SPI DENTAL IMPLANT ABUTMENTS
K031747 · NHA
Thommen Medical AG
Dental · 27d
Cleared Jul 02, 2003
SYNTHES LOW PROFILE NEURO SYSTEM - 3 MM SCREWS
K031807 · DZL
Synthes (Usa)
Dental · 21d
Cleared Jun 30, 2003
APEX ELECTRIC HANDPIECE SYSTEM
K031540 · EKX
Lares Research, Inc.
Dental · 45d
Cleared Jun 27, 2003
RAPID IMF
K030605 · DYX
Zygomatics , Ltd.
Dental · 122d
Cleared Jun 27, 2003
CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8037-3
K030682 · LYC
Bioform, Inc.
Dental · 114d
Cleared Jun 25, 2003
DETECTAR, MODEL N123-MI
K023367 · EJB
Neks Technologies
Dental · 260d
Cleared Jun 25, 2003
MIRACLE 98
K031010 · EJT
Sb Lucius, Inc.
Dental · 86d
Cleared Jun 19, 2003
C-1805M
K023815 · EIA
Anodia Systems
Dental · 216d
Cleared Jun 19, 2003
C-1890
K023896 · EIA
Anodia Systems
Dental · 209d
Cleared Jun 19, 2003
UFI GEL HARD C
K030916 · EBI
Voco GmbH
Dental · 87d
Cleared Jun 17, 2003
IMAGINE REFLEX
K031326 · EIH
Wieland Dental + Technik GmbH & Co. KG
Dental · 53d