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
1081–1104 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared May 17, 2022
Neoss Individual Prosthetics
K211396 · NHA
Neoss, Ltd.
Dental · 377d
Cleared May 13, 2022
Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)
K212475 · EJK
Prevest Denpro Limited
Dental · 280d
Cleared May 11, 2022
Disposable Barrier Sleeves
K220662 · PEM
Premium Plus (Dongguan) Limited
Dental · 65d
Cleared May 10, 2022
Dental diode laser
K214008 · NVK
Shenzhen Soga Technology Co., Ltd.
Dental · 139d
Cleared May 09, 2022
CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy...
K213022 · EBW
Cefla S.C.
Dental · 231d
Cleared May 06, 2022
Vatech Clismile
K220689 · NJM
Rayence Co., Ltd.
Dental · 58d
Cleared Apr 29, 2022
TIA Tip, Cariosity, Transillumination Accessory Tip
K213482 · NTK
D4D Technologies, LLC
Dental · 182d
Cleared Apr 28, 2022
Ortholock Anchorage Devices
K202691 · OAT
Craniofacial Technologies, Inc.
Dental · 590d
Cleared Apr 21, 2022
Venus Bulk Flow ONE
K220605 · EBF
Kulzer, LLC
Dental · 50d
Cleared Apr 14, 2022
High Retention Attachment System
K220252 · NHA
Zest Anchors, LLC
Dental · 73d
Cleared Apr 13, 2022
ZENEX Implant System
K211090 · DZE
Izenimplant Co., Ltd.
Dental · 366d
Cleared Apr 08, 2022
TLX SRAs and TLX Gold Abutments
K213063 · NHA
Institut Straumann AG
Dental · 197d
Cleared Apr 08, 2022
Thermeo System
K212017 · MQC
Pro3dure Medical GmbH
Dental · 284d
Cleared Apr 07, 2022
Invisalign System
K220287 · NXC
Align Technology, Inc.
Dental · 65d
Cleared Apr 06, 2022
NB 1 SA Implant System
K213506 · DZE
Arum Dentistry Co., Ltd.
Dental · 156d
Cleared Apr 05, 2022
Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed,...
K212463 · NPL
Geistlich Pharma AG
Dental · 242d
Cleared Apr 04, 2022
TRATE Dental Implant System
K220022 · DZE
Trate AG
Dental · 89d
Cleared Apr 01, 2022
MIS Angulated multi-unit abutments
K213432 · NHA
Dentsply Sirona
Dental · 161d
Cleared Mar 28, 2022
T3 Pro Implants
K213672 · DZE
Biomet 3i, LLC
Dental · 126d
Cleared Mar 28, 2022
CERABIEN MiLai
K213147 · EIH
Kuraray Noritake Dental, Inc.
Dental · 182d
Cleared Mar 18, 2022
BeautiBond Xtreme
K213965 · KLE
Shofu Dental Corporation
Dental · 88d
Cleared Mar 18, 2022
Vintage Prime Press
K212939 · EIH
Shofu Dental Corporation
Dental · 184d
Cleared Mar 17, 2022
SICtapered & SICvantage tapered
K210489 · DZE
Sic Invent AG
Dental · 391d
Cleared Mar 16, 2022
K Clear
K220726 · NXC
Kline Europe GmbH
Dental · 2d