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
793–816 of 12,659
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Sep 15, 2023
LW UCLA Abutment
K231235 · NHA
Ossvis Co., Ltd.
Dental · 140d
Cleared Sep 14, 2023
LightForce Orthodontic System
K232827 · NJM
Lightforce Orthodontics
Dental · 1d
Cleared Sep 14, 2023
LW Retraction Cap
K231079 · NHA
Ossvis Co., Ltd.
Dental · 150d
Cleared Sep 14, 2023
Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7,...
K230237 · MQC
Hkable 3D Biologic Printing...
Dental · 227d
Cleared Sep 14, 2023
Straumann® BLC and TLC Implants
K230108 · DZE
Institut Straumann AG
Dental · 244d
Cleared Sep 07, 2023
Gradual Dental Zirconia Blank
K231687 · EIH
Liaoning Upcera Co., Ltd.
Dental · 90d
Cleared Sep 07, 2023
Signum opaque F
K230644 · EBF
Kulzer, LLC
Dental · 183d
Cleared Sep 05, 2023
Polibond
K232691 · EBI
Zirkonzahn Srl
Dental · 4d
Cleared Sep 01, 2023
InnerView LC
K232657 · EKX
Perimetrics, Inc.
Dental · 1d
Cleared Sep 01, 2023
TRIOCLEAR System
K231884 · NXC
Modern Dental Laboratory (Dg) Co., Ltd.
Dental · 66d
Cleared Sep 01, 2023
Elos Accurate Hybrid Base
K230317 · NHA
Elos Medtech Pinol A/S
Dental · 207d
Cleared Sep 01, 2023
ApneaRX Pro
K223901 · LRK
Apnea Sciences Coporation
Dental · 247d
Cleared Aug 24, 2023
Stryker MP, Mandible, HMMF and MMF AXS Screws
K231599 · DZL
Stryker Leibinger GmbH & Co KG
Dental · 84d
Cleared Aug 24, 2023
ZENEX FreeMilling & CCM Cast Abutment
K231557 · NHA
Izenimplant Co., Ltd.
Dental · 86d
Cleared Aug 23, 2023
EVO 700 series high speed handpiece
K232243 · EFB
Ttbio Corp.
Dental · 26d
Cleared Aug 23, 2023
Oneday Mini Implant System
K222946 · DZE
Oneday Biotech Co., Ltd.
Dental · 330d
Cleared Aug 22, 2023
GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray
K231205 · LFD
Gurunanda, LLC
Dental · 117d
Cleared Aug 21, 2023
ACR Screw System
K222245 · OAT
Biomaterials Korea, Inc.
Dental · 391d
Cleared Aug 18, 2023
UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro -...
K232498 · EBC
Ultradent Product, Inc.
Dental · 1d
Cleared Aug 18, 2023
Eco Abutment, Multiunit Abutment
K220253 · NHA
Dio Corporation
Dental · 564d
Cleared Aug 17, 2023
InterCollagen® Guide
K223912 · NPL
Sigmagraft, Inc.
Dental · 231d
Cleared Aug 16, 2023
Harvest Dental HD Gum Strip
K231389 · EBI
Harvest Dental Products, LLC
Dental · 96d
Cleared Aug 15, 2023
Implant-One System
K231455 · NHA
Implant Logistics, Inc.
Dental · 89d
Cleared Aug 14, 2023
DESS Dental Smart Solutions
K231434 · NHA
Terrats Medical SL
Dental · 89d