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
601–624 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Apr 05, 2024
DigiLine Direct Print Aligner System
K233935 · NXC
Park Dental Research Corporation
Dental · 113d
Cleared Apr 04, 2024
Clear Moves Aligners
K240038 · NXC
Space Maintainers Laboratories (Sml)
Dental · 90d
Cleared Apr 03, 2024
Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX
K232653 · NXC
Blue Sky Bio, LLC
Dental · 216d
Cleared Apr 02, 2024
Calibra Abutment Resin Cement
K240888 · EMA
Dentsply Sirona
Dental · 1d
Cleared Apr 01, 2024
External Hex Implant System
K232726 · DZE
Southern Implants (Pty), Ltd.
Dental · 208d
Cleared Apr 01, 2024
CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO
K230895 · EBW
Cefla S.C.
Dental · 367d
Cleared Mar 28, 2024
IS-III active Short Implant
K232049 · DZE
Neobiotech Co., Ltd.
Dental · 262d
Cleared Mar 26, 2024
RODIN 3D Resin SPLINT, Hard/Flex
K231793 · MQC
Belport Company, Inc., Gingi-Pak
Dental · 280d
Cleared Mar 26, 2024
J & P Click Attachments
K231132 · NHA
J & P Dental Technologies
Dental · 340d
Cleared Mar 25, 2024
LUNE™ PureHygiene
K234085 · GEX
Enamel Pure
Dental · 94d
Cleared Mar 25, 2024
LW Implant System – Abutment
K233167 · NHA
Ossvis Co., Ltd.
Dental · 180d
Cleared Mar 25, 2024
STERI-OSS Implant System
K232268 · DZE
Zeros Co., Ltd.
Dental · 238d
Cleared Mar 21, 2024
N2
K240754 · EIA
Megagen Implant Co., Ltd.
Dental · 1d
Cleared Mar 20, 2024
Peak Universal Bond
K240743 · KLE
Ultradent Products, Inc.
Dental · 2d
Cleared Mar 20, 2024
BruxZir® Radiant
K240574 · EIH
Prismatik Dentalcraft, Inc.
Dental · 19d
Cleared Mar 20, 2024
Straumann® BLC and TLC Implants - Line extension
K234049 · DZE
Institut Straumann AG
Dental · 90d
Cleared Mar 19, 2024
Pre-Sintered Zirconia Coloring Liquid
K232682 · EIH
Chengdu Besmile Medical Technology...
Dental · 200d
Cleared Mar 15, 2024
FORMA Composite (Shade A3D)
K240694 · EBF
Ultradent Products, Inc.
Dental · 1d
Cleared Mar 15, 2024
Light Cure Composite
K240112 · EBF
Sincera Technology (Changchun) Co., Ltd.
Dental · 59d
Cleared Mar 14, 2024
CloudPoint FastDesign Chairside
K231529 · PNP
Prismatik Dentalcraft, Inc.
Dental · 293d
Cleared Mar 12, 2024
Align Studio
K232564 · PNN
Laon Medi, Inc.
Dental · 201d
Cleared Mar 11, 2024
Caphosol® Artifical Saliva (32 doses sachet box)
K234015 · LFD
Eusa Pharma (Uk) Limited
Dental · 83d
Cleared Mar 11, 2024
SP NEWTRON CAN-A
K233922 · ELC
Satelec - Acteon Group
Dental · 89d
Cleared Mar 11, 2024
Fiber Optic Brushless Electronic Micromotor, model: iM100
K231864 · EBW
Codent Technical Industry Co., Ltd.
Dental · 259d