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
577–600 of 12,595
Search insights Median review: 86d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Apr 25, 2024
Temporis, Irix Plus
K231142 · EBF
Dws S.R.L.
Dental · 370d
Cleared Apr 24, 2024
DESS Dental Smart Solutions
K240208 · NHA
Terrats Medical SL
Dental · 90d
Cleared Apr 19, 2024
Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)
K240508 · LFD
Laclede, Inc.
Dental · 58d
Cleared Apr 18, 2024
Difiney Anti Snoring Device
K233850 · LRK
Fissiontech, LLC
Dental · 135d
Cleared Apr 17, 2024
Goyo Mouthpiece S
K232238 · OBR
Dimedikorea
Dental · 264d
Cleared Apr 15, 2024
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM...
K223113 · NHA
Medentika GmbH
Dental · 560d
Cleared Apr 12, 2024
UltraThineer Zirconia Slurry (5Y-B)
K240419 · EIH
Boston Micro Fabrication
Dental · 59d
Cleared Apr 11, 2024
Ni2 Implant System
K221847 · DZE
Newton Implant Systems, Inc.
Dental · 657d
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