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
1609–1632 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Feb 13, 2020
Implacil Implant System
K183024 · DZE
Implacil DE Bortoli Material...
Dental · 469d
Cleared Feb 11, 2020
ULab Systems Dental Aligner Kit
K192596 · NXC
Ulab Systems, Inc.
Dental · 144d
Cleared Feb 11, 2020
Cervitec F
K191453 · LBH
Ivoclar Vivadent, AG
Dental · 256d
Cleared Feb 10, 2020
Argen Clear Aligner, Argen Clear Aligner Premium
K192846 · NXC
Argen Corporation
Dental · 130d
Cleared Feb 10, 2020
Elos Accurate Hybrid Base
K191919 · NHA
Elos Medtech Pinol A/S
Dental · 207d
Cleared Feb 10, 2020
K3Pro Konus New Abutments and Implants
K190192 · DZE
Argon Med. Productions Vertriebs...
Dental · 371d
Cleared Feb 07, 2020
DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill...
K192273 · KLE
DiaDent Group International
Dental · 169d
Cleared Feb 06, 2020
Elos Accurate Customized Abutment
K191890 · NHA
Elos Medtech Pinol A/S
Dental · 206d
Cleared Feb 05, 2020
DENTCA Crown and Bridge
K192806 · EBG
Dentca, Inc.
Dental · 127d
Cleared Feb 05, 2020
Respire Pink AT (Hard, Hard/Soft, EF)
K192127 · LRK
Respire Medical Holdings
Dental · 183d
Cleared Feb 05, 2020
Infinity / Infinity Cross Flex Dental Systems
K180935 · EIA
Olsen Industria E Comercio S.A.
Dental · 666d
Cleared Feb 04, 2020
s-Clean SQ-SL Implant System Regular
K192688 · DZE
Dentis Co., Ltd.
Dental · 131d
Cleared Feb 03, 2020
X-Guide Surgical Navigation System
K192579 · PLV
X-Nav Technologies, LLC
Dental · 137d
Cleared Jan 31, 2020
Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia
K192535 · EIH
Qinhuangdao Audental Metal Technology...
Dental · 137d
Cleared Jan 30, 2020
Noritake Super Porcelain EX-3
K193060 · EIH
Kuraray Noritake Dental, Inc.
Dental · 90d
Cleared Jan 30, 2020
HySil Super Fast Impression Materials
K192941 · ELW
Osstem Implant Co., Ltd.
Dental · 104d
Cleared Jan 29, 2020
VITA VIONIC Bond
K191926 · EBI
Vita Zanhnfabrik H. Rauter GmbH Co.
Dental · 195d
Cleared Jan 29, 2020
UniSmile Clear Aligner System
K191837 · NXC
Vitang Technology, LLC
Dental · 204d
Cleared Jan 29, 2020
TruAbutment DS
K183106 · NHA
Truabutment, Inc.
Dental · 447d
Cleared Jan 28, 2020
The NightBlocks Appliance
K192581 · LQZ
Advanced Facialdontics, LLC
Dental · 131d
Cleared Jan 23, 2020
Surefil one Self-adhesive Composite Hybrid
K192530 · EMA
Dentsply Sirona
Dental · 129d
Cleared Jan 23, 2020
Healing Abutments and Cover Screws
K192436 · NHA
Dentium Co., Ltd.
Dental · 139d
Cleared Jan 23, 2020
FiteBac Cavity Cleanser
K190271 · LBH
Largent Health, LLC
Dental · 349d
Cleared Jan 22, 2020
Internal Hex Implant System
K190837 · DZE
Ebi, Inc.
Dental · 296d