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
1129–1152 of 12,659
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