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
193–216 of 12,659
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