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
457–480 of 12,659
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Dec 19, 2024
Cristaline Aligners Z FLX
K242892 · NXC
Cristaline Aligners GmbH
Dental · 87d
Cleared Dec 19, 2024
IPD Dental Implant Abutments
K242819 · NHA
Implant Protesis Dental 2004, S.L.
Dental · 92d
Cleared Dec 18, 2024
3Delta UNlimited
K243720 · EBF
Deltamed GmbH
Dental · 15d
Cleared Dec 17, 2024
Lucitone Digital Print Denture™ System
K243336 · EBI
Dentsply Sirona, Inc.
Dental · 54d
Cleared Dec 17, 2024
Quantium
K242816 · EBF
Bisco, Inc.
Dental · 90d
Cleared Dec 17, 2024
ALLONUS Tech Prosthetics
K241616 · NHA
Allonus Tech Co., Ltd.
Dental · 195d
Cleared Dec 16, 2024
Dental Implants and Abutments
K243066 · DZE
Ditron Dental, Ltd.
Dental · 80d
Cleared Dec 12, 2024
Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)
K242934 · KIF
Longly Biotechnology (Wuhan) Co., Ltd.
Dental · 78d
Cleared Dec 12, 2024
visio.lign color, visio.lign shield
K240735 · EBD
Bredent GmbH & Co. KG
Dental · 269d
Cleared Dec 12, 2024
GENIOVA aligners
K233152 · NXC
Geniova Technologies Sociedad Limitada
Dental · 442d
Cleared Dec 11, 2024
TECHFIT DISRP® System
K242263 · DZJ
Techfit Digital Surgery, Inc.
Dental · 132d
Cleared Dec 10, 2024
Elos Accurate® Hybrid Base™
K242025 · NHA
Elos Medtech Pinol A/S
Dental · 152d
Cleared Dec 10, 2024
Straumann® PURE Ceramic Implants
K241391 · DZE
Institut Straumann AG
Dental · 209d
Cleared Dec 05, 2024
Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO)
K242740 · EIH
Liaoning Rachcera Material Technology...
Dental · 85d
Cleared Dec 05, 2024
LW Pre-milled Abutment
K242703 · NHA
Ossvis Co., Ltd.
Dental · 87d
Cleared Dec 04, 2024
Neodent Implant System
K242686 · NHA
Jjgc Ind?stria E Com?rcia DE...
Dental · 89d
Cleared Nov 27, 2024
C&B Ceramic
K233273 · EBF
Prevest Denpro Limited
Dental · 425d
Cleared Nov 26, 2024
Digital Temp
K242559 · EBG
Sprintray, Inc.
Dental · 90d
Cleared Nov 26, 2024
PrimmaArt
K231859 · EBG
Dentscare Ltda
Dental · 522d
Cleared Nov 25, 2024
Customized Abutment
K242245 · NHA
Arum Dentistry Co., Ltd.
Dental · 117d
Cleared Nov 25, 2024
MIS LYNX Conical Connection Implant System
K241692 · DZE
Dentsply Sirona, Inc.
Dental · 166d
Cleared Nov 22, 2024
Jasmate® Toothpaste
K242913 · LBH
Jasberry Healthcare Private Limited
Dental · 59d
Cleared Nov 22, 2024
Additively Manufactured Denture Resin
K242884 · EBI
Aidite (Qinhuangdao) Technology Co.,...
Dental · 60d
Cleared Nov 20, 2024
Estar-ZE
K242521 · EIH
Osstem Implant Co., Ltd.
Dental · 89d