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
3217–3240 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jan 29, 2013
INION CPS ORBITAL PLATES
K122890 · JEY
Inion OY
Dental · 131d
Cleared Jan 24, 2013
SR NEXCO PASTE LAYERING MATERIALS, SR NEXCO OPAQUER, SR NEXCO LINER-SR NEXCO...
K123304 · EBF
Ivoclar Vivadent, AG
Dental · 92d
Cleared Jan 23, 2013
OSSEOSPEED ANGLED ABUTMENT EV
K121810 · NHA
Astra Tech AB
Dental · 217d
Cleared Jan 17, 2013
HERO I DENTAL IMPLANT SYSTEM
K121098 · DZE
Kj Meditech Co., Ltd.
Dental · 281d
Cleared Jan 16, 2013
OCS-B
K113246 · NPM
Nibec Company, Limited
Dental · 441d
Cleared Jan 14, 2013
REMESENSE FOR SENSITIVE TEETH
K122708 · LBH
Sylphar N.V.
Dental · 132d
Cleared Jan 10, 2013
NEW COMFORT-FIT DENTAL GUARD
K123849 · OBR
Den Tek Oral Care, Inc.
Dental · 27d
Cleared Jan 10, 2013
I.FLEX BY TCS
K123396 · EBI
Thermoplastic Comfort Systems, Inc.
Dental · 66d
Cleared Jan 10, 2013
MEDTRONIC XOMED, INC.
K122391 · LRK
Medtronic Xomed, Inc.
Dental · 156d
Cleared Jan 10, 2013
DETECT
K121206 · LQY
Forum Engineering Technologies, Ltd.
Dental · 265d
Cleared Jan 08, 2013
SOLOCEM
K121621 · EMA
Coltene/Whaledent AG
Dental · 221d
Cleared Jan 07, 2013
TS IMPLANT SYSTEM
K121585 · DZE
Osstem Implant Co., Ltd.
Dental · 221d
Cleared Jan 04, 2013
BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING...
K123731 · LFD
Glaxosmithkline Consumer Healthcare...
Dental · 30d
Cleared Jan 04, 2013
THERASOM-CAST
K113516 · LRK
Family Dental Services, P.C.
Dental · 402d
Cleared Jan 03, 2013
COLLADENTAL BARRIER
K100695 · NPL
Collamatrix, Inc.
Dental · 1029d
Cleared Dec 27, 2012
KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B
K122039 · EBG
Kettenbach GmbH & Co. KG
Dental · 169d
Cleared Dec 21, 2012
X-TRA BASE
K123773 · EBF
Voco GmbH
Dental · 14d
Cleared Dec 21, 2012
CERAMIN BRACKETS Z
K123092 · NJM
Tomy, Inc.
Dental · 80d
Cleared Dec 21, 2012
STRAUMANN CARES VARIOBASE ABUTMENT NNC, STRAUMANN CARES VARIOBASE ABUTMENT...
K120822 · NHA
Institut Straumann AG
Dental · 277d
Cleared Dec 21, 2012
Z-LOOK3 EVO SLM
K120793 · DZE
Z-Systems AG
Dental · 281d
Cleared Dec 20, 2012
SYNTEC DENTAL IMPLANT
K111189 · DZE
Syntec Scientific Corp.
Dental · 602d
Cleared Dec 20, 2012
CURASAN OSSEOLIVE DENTAL
K111105 · LYC
Curasan AG
Dental · 610d
Cleared Dec 18, 2012
TRAUS SIP10
K123695 · EKY
Saeshin Precision Co., Ltd.
Dental · 15d
Cleared Dec 14, 2012
EMPOWER CLEAR
K122753 · NJM
American Orthodontics
Dental · 98d