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
4105–4128 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jun 04, 2009
SPEEDCEM
K091019 · EMA
Ivoclar Vivadent, Inc.
Dental · 56d
Cleared May 27, 2009
FLUID FILLED TEETHER
K082824 · KKO
Kids II
Dental · 244d
Cleared May 27, 2009
ORTHODONTIC CERAMIC BRACKET
K090567 · NJM
Star Dentech Korea., Corp
Dental · 85d
Cleared May 22, 2009
STRAUMANN MEMBRAGEL
K082111 · NPK
Institut Straumann AG
Dental · 298d
Cleared May 22, 2009
ANKYLOS C/X DENTAL IMPLANT SYSTEM
K083805 · DZE
Dentsply Intl., Inc.
Dental · 151d
Cleared May 22, 2009
NEOSS IMPLANT SYSTEM 03.25
K090452 · DZE
Neoss, Ltd.
Dental · 88d
Cleared May 22, 2009
MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES
K090676 · EFA
Anthogyr
Dental · 70d
Cleared May 21, 2009
ORALUBE
K090457 · ONK
Pulpdent Corporation
Dental · 87d
Cleared May 21, 2009
METAMORPHOSIS
K091023 · EBF
Kerr Corporation
Dental · 41d
Cleared May 19, 2009
BRANEMARK INTEGRATION BIOHELIX IMPLANTS
K090005 · DZE
Branemark Integration AB
Dental · 137d
Cleared May 19, 2009
BONGROS HA
K090793 · LYC
Bioalpha, Inc.
Dental · 56d
Cleared May 15, 2009
SPECTRA SYSTEM DENTAL IMPLANTS 2008
K090234 · DZE
Implant Direct, LLC
Dental · 105d
Cleared May 11, 2009
PULPDENT MICRO-HYBRID COMPOSITE
K090391 · EBF
Pulpdent Corporation
Dental · 83d
Cleared May 11, 2009
MONOBOND PLUS
K090826 · KLE
Ivoclar Vivadent, Inc.
Dental · 46d
Cleared May 08, 2009
GRIND NO MORE VERSION 2 AND 3
K091175 · OBR
Ranir, LLC
Dental · 16d
Cleared May 07, 2009
PROCERA IMPLANT BRIDGE OVERDENTURE
K090069 · NHA
Nobel Biocare AB
Dental · 115d
Cleared May 06, 2009
VONFLEX PUTTY
K091267 · ELW
Vericom Co., Ltd.
Dental · 6d
Cleared May 05, 2009
INCLUSIVE ZIRCONIA ABUTMENT BLANKS
K083480 · NHA
Inclusive Dental Solutions
Dental · 162d
Cleared May 01, 2009
HS II SHORT FIXTURE SYSTEM
K083633 · DZE
Osstem Implant Co., Ltd.
Dental · 144d
Cleared May 01, 2009
VIVID, MODELS 40-A0001, 40-A0004, 40-A0006
K090079 · EIA
Progeny, Inc.
Dental · 109d
Cleared May 01, 2009
AVANTE LEUCITE BLOCKS
K090684 · EIH
Somerset Dental Products, Inc.
Dental · 46d
Cleared Apr 30, 2009
SYNTHES 90 DEGREE SCREWDRIVER
K082649 · DZI
Synthes (Usa)
Dental · 230d
Cleared Apr 29, 2009
I-FIX SYSTEM
K083586 · DZE
Dentis Co., Ltd.
Dental · 146d
Cleared Apr 29, 2009
OPAL SEAL
K090355 · DYH
Ultradent Products, Inc.
Dental · 77d