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
145–168 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
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
Cleared Dec 18, 2025
Dental Cone
K253758 · OLR
Medizin Produkte Neustadt GmbH (Mpn)
Dental · 23d
Cleared Dec 18, 2025
Park Dental Nylon MAD
K252976 · LRK
Park Dental Research Corp.
Dental · 92d
Cleared Dec 18, 2025
SIMDA Abutments
K252320 · NHA
Simda Co., Ltd.
Dental · 146d
Cleared Dec 12, 2025
TopCEM Vigor SA Self-Adhesive Resin Cement
K252785 · EMA
Rizhao Huge Biomaterials Company, Ltd.
Dental · 101d
Cleared Dec 12, 2025
Pterygoid Indication for GM Helix Implants
K252090 · DZE
JJGC Ind?stria e Com?rcio de...
Dental · 163d
Cleared Dec 12, 2025
Jason membrane
K242817 · NPL
Botiss Biomaterials GmbH
Dental · 450d
Cleared Dec 09, 2025
GlasIonomer FX-LC
K252808 · EMA
Shofu Dental Corporation
Dental · 97d
Cleared Dec 09, 2025
Atlantis® Abutments in Titanium
K252343 · NHA
Dentsply Sirona
Dental · 134d