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
121–144 of 12,595
Search insights Median review: 86d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jan 28, 2026
GBT Machine Airflow Prophylaxis Master
K253254 · ELC
E.M.S Electro Medical Systems S.A
Dental · 121d
Cleared Jan 22, 2026
Straumann Variobase Abutments XC for Bridge/Bar
K253315 · NHA
Institut Straumann AG
Dental · 114d
Cleared Jan 22, 2026
IPDmilled Blanks
K253253 · NHA
Implant Protesis Dental 2004, S.L.
Dental · 115d
Cleared Jan 21, 2026
LumiCera
K260170 · EBF
Hangzhou SHINING3D Dental Technology...
Dental · 1d
Cleared Jan 13, 2026
Bright Cavity Liner
K253248 · EJK
Dmp Dental Industry S.A.
Dental · 106d
Cleared Jan 12, 2026
Any-Paste
K253167 · KIF
Mediclus Co., Ltd.
Dental · 108d
Cleared Jan 12, 2026
Star E900 Electric System
K251701 · EBW
Dentalez, Inc., Stardental Division
Dental · 224d
Cleared Jan 12, 2026
High speed air turbine handpiece
K251389 · EFB
Foshan Topmed Dental Co., Ltd.
Dental · 252d
Cleared Jan 12, 2026
Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS,...
K251388 · EFB
Foshan Topmed Dental Co., Ltd.
Dental · 252d
Cleared Jan 09, 2026
Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series
K253973 · EIH
Liaoning Upcera Co., Ltd.
Dental · 29d
Cleared Jan 08, 2026
ZENEX Implant System_R-System
K252585 · DZE
Izenimplant Co., Ltd.
Dental · 146d
Cleared Jan 07, 2026
ZenSeal Pro
K252890 · KIF
Kerr Corporation
Dental · 118d
Cleared Jan 07, 2026
Neodent InLab Validated Workflow
K252727 · NHA
JJGC Ind?stria e Com?rcio de...
Dental · 132d
Cleared Jan 07, 2026
SmileInspector
K252507 · PNN
Amv Consulting, LLC
Dental · 152d
Cleared Jan 07, 2026
Clear Aligner (SCF-3348)
K251454 · NXC
Beame Medical Technology (Shenzhen)...
Dental · 240d
Cleared Dec 29, 2025
Celebrace Software
K253343 · PNN
Celebrace
Dental · 90d
Cleared Dec 23, 2025
VarioSurg 4
K254163 · DZI
Nakanishi, Inc.
Dental · 1d
Cleared Dec 23, 2025
Custom Abutments AS
K253341 · NHA
Medentika GmbH
Dental · 84d
Cleared Dec 23, 2025
OrangeCAD Med Abutments
K253312 · NHA
Orangecad Med GmbH
Dental · 84d
Cleared Dec 23, 2025
GEN5™ and GEN5+™ 3.3mmD Dental Implants
K252145 · DZE
Paragon Implant Mfg., LLC
Dental · 167d
Cleared Dec 23, 2025
NizPlant Dental Implant System
K250476 · DZE
Paragon Implant Mfg., LLC
Dental · 307d
Cleared Dec 22, 2025
DIMPLO Implant System
K251605 · DZE
DIMPLO, Ltd.
Dental · 209d
Cleared Dec 19, 2025
iCEM Universal Plus
K254063 · EMA
Kulzer, LLC
Dental · 2d
Cleared Dec 19, 2025
Southern Craniomaxillofacial (CMF) System
K253373 · JEY
Southern Medical (Pty) , Ltd.
Dental · 80d