Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Dental ×
12,659 results
1657–1680 of 12,659
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