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
4297–4320 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Sep 05, 2008
ARDS DENTAL IMPLANTS
K071803 · DZE
Ards, Ltd.
Dental · 431d
Cleared Sep 05, 2008
CARBOXYLATE CEM, PHOSPHATE CEM
K081702 · EMA
S & C Polymer GmbH
Dental · 80d
Cleared Sep 05, 2008
MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM
K081747 · NEI
Synthes (Usa)
Dental · 78d
Cleared Sep 05, 2008
METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER
K081913 · EMA
Meta Biomed Co., Ltd.
Dental · 64d
Cleared Sep 05, 2008
3M UNITEK LAVA CHAIRSIDE ORAL SCANNER
K081961 · NOF
Brontes Technologies
Dental · 58d
Cleared Sep 05, 2008
FORTOSS VITAL
K082383 · LYC
Biocomposites, Ltd.
Dental · 17d
Cleared Sep 04, 2008
SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS
K080089 · ELC
Sybron Dental Specialties, Inc.
Dental · 234d
Cleared Sep 03, 2008
SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS
K073478 · EFB
Sybron Dental Specialties, Inc.
Dental · 267d
Cleared Sep 03, 2008
MS SYSTEM (NARROW RIDGE)
K080594 · DZE
Osstem Implant Co., Ltd.
Dental · 184d
Cleared Sep 02, 2008
HU/HS/HG PROSTHETIC SYSTEM
K081575 · NHA
Osstem Implant Co., Ltd.
Dental · 89d
Cleared Aug 29, 2008
PERIMETRICS PERIOMETER
K072213 · EKX
Perimetrics, Inc.
Dental · 386d
Cleared Aug 29, 2008
OTA COLLAGEN BIOMATERIAL
K073685 · NPL
Osseous Technologies of America
Dental · 245d
Cleared Aug 29, 2008
HEALOS II BONE GRAFT SUBSTITUTE
K081432 · LYC
Depuy Spine, Inc.
Dental · 100d
Cleared Aug 29, 2008
PLANMECA SOVEREIGN
K081699 · EIA
Planmeca USA, Inc.
Dental · 73d
Cleared Aug 29, 2008
LUTE-IT II VENEER CEMENT, MODEL NO6
K081887 · EMA
Pentron Clinical Technologies
Dental · 58d
Cleared Aug 28, 2008
BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO
K081550 · ELC
Bonart Co., Ltd.
Dental · 86d
Cleared Aug 25, 2008
BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES
K080761 · DZI
Bonart Co., Ltd.
Dental · 160d
Cleared Aug 25, 2008
CRAFTMASTER CONTOUR EQUIPMENT, INC., VISTA MODEL V-20, SATELLITE MOBILE UNIT...
K081237 · EIA
Craftmaster Contour Equipment, Inc.
Dental · 116d
Cleared Aug 22, 2008
WESTAR SERIES DENTAL UNITS
K082294 · EIA
Westar Medical Products, Inc.
Dental · 10d
Cleared Aug 21, 2008
ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW
K081393 · OAT
G & H Wire Co.
Dental · 94d
Cleared Aug 21, 2008
XERACEM
K081405 · EMA
Doxa Dental AB
Dental · 94d
Cleared Aug 15, 2008
RESCUE EXTERNAL IMPLANT SYSTEM
K081302 · DZE
Megagen Implant Co., Ltd.
Dental · 99d
Cleared Aug 12, 2008
DMC COMPOSITE
K081695 · EBF
Kerr Corp.
Dental · 56d
Cleared Aug 08, 2008
DENTAL PORCELAIN (GLASS POWDER), TOP-CERAM T-1, T1, T2, T3, T4
K081200 · EIH
Global Top, Inc.
Dental · 102d