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
3001–3024 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jan 14, 2014
SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S
K132984 · ELM
Ivoclar Vivadent, Inc.
Dental · 112d
Cleared Jan 10, 2014
ET PROSTHETIC SYSTEM
K130662 · NHA
Osstem Implant Co., Ltd.
Dental · 304d
Cleared Jan 10, 2014
SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY
K130235 · NUN
Hans Biomed Corp.
Dental · 345d
Cleared Jan 09, 2014
LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM
K121235 · JEY
Stryker
Dental · 625d
Cleared Jan 08, 2014
3I T3(R) EXTERNAL HEX DENTAL IMPLANTS
K133049 · DZE
Biomet 3i
Dental · 103d
Cleared Jan 08, 2014
ORTHODONTIC MINISCREW FOR ABSOLUTE ANCHORAGE
K130476 · OAT
Dental Morelli
Dental · 317d
Cleared Jan 03, 2014
FUSION SINGLE LINK
K132923 · KLE
Angelus Industria DE Productos...
Dental · 107d
Cleared Dec 24, 2013
INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM
K130572 · DZE
Implant Direct Sybron Manufacturing, LLC
Dental · 295d
Cleared Dec 20, 2013
REST ASSURED EXTRA COMFORT NITE PROTECTOR
K133423 · OBR
Ranir, LLC
Dental · 42d
Cleared Dec 20, 2013
K-ETCHANT SYRINGE
K133078 · KLE
Kuraray Noritake Dental, Inc.
Dental · 84d
Cleared Dec 20, 2013
MULTI ANGLED ABUTMENT SYSTEM
K132067 · NHA
Hiossen, Inc.
Dental · 170d
Cleared Dec 20, 2013
POLYDIMETHYLSILOXANE IMPRESSION MATERIAL
K131510 · ELW
Blackwell Device Consulting
Dental · 210d
Cleared Dec 19, 2013
VAPOR CERAMIC BRACKET
K132368 · NJM
Orthodontic Design and Production, Inc.
Dental · 142d
Cleared Dec 18, 2013
TI STAR IMPLANT SYSTEM
K132992 · DZE
T-Plus Implant Tech. Co., Ltd.
Dental · 85d
Cleared Dec 18, 2013
COPRA TEMP PMMA-DISK
K131664 · EBG
White Peaks Dental Systems GmbH & Co. KG
Dental · 194d
Cleared Dec 18, 2013
LUCO HYBRID OSA APPLIANCE
K130797 · LRK
Luco Hybrid Osa Appliance, Inc.
Dental · 271d
Cleared Dec 12, 2013
AIDI DENTAL IMPLANT SYSTEM
K123861 · DZE
Aidi Biomedical, LLC
Dental · 363d
Cleared Dec 11, 2013
AVINENT DENTAL IMPLANT SYSTEM
K121873 · DZE
Avinent Implant System S.L.
Dental · 532d
Cleared Dec 06, 2013
STRYKER CUSTOMIZED MANDIBLE RECON PLATE KIT
K132519 · JEY
Stryker
Dental · 116d
Cleared Dec 06, 2013
PIEZON 250
K132445 · ELC
E.M.S Electro Medical Systems S.A
Dental · 122d
Cleared Dec 06, 2013
INNO SLA SUBMERGED IMPLANT SYSTEM
K132242 · DZE
Cowellmedi Co., Ltd.
Dental · 141d
Cleared Dec 05, 2013
STARCERAM
K133213 · EIH
H.C. Starck Ceramics GmbH
Dental · 48d
Cleared Dec 05, 2013
UD IMPLANT SYSTEM
K131682 · DZE
Medimecca Co., Ltd.
Dental · 178d
Cleared Dec 05, 2013
BOND APATITE
K121177 · LYC
Augma Biomaterials, Ltd.
Dental · 596d