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
649–672 of 12,659
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