FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Dental ×
12,595 results
1057–1080 of 12,595
Search insights Median review: 86d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jun 01, 2022
DeltaFil, DeltaFil Conditioner
K213201 · EMA
Dmg Chemisch Pharmazeutische Fabrik GmbH
Dental · 245d
Cleared May 31, 2022
Respire Clear
K214096 · LRK
Respire Medical, LLC
Dental · 154d
Cleared May 31, 2022
LuxCreo Clear Aligner System
K212680 · NXC
LuxCreo, Inc.
Dental · 280d
Cleared May 26, 2022
AMADEO, M-UK1015 (incl. attachments and accessories)
K213221 · ERL
W&H Dentalwerk Buermoss GmbH
Dental · 239d
Cleared May 25, 2022
Paltop Conical Implant System
K220200 · DZE
Paltop Advanced Dental Solutions, Ltd.
Dental · 121d
Cleared May 25, 2022
OptiComp
K202920 · EBF
Pac-Dent, Inc.
Dental · 603d
Cleared May 23, 2022
DailyMate Orthodontic Aligner System
K212803 · NXC
3D Global Biotech, Inc.
Dental · 263d
Cleared May 23, 2022
CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical...
K212563 · KIF
Prevest Denpro Limited
Dental · 283d
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