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
1921–1944 of 12,659
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jan 07, 2019
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM...
K180564 · NHA
Medentika GmbH
Dental · 308d
Cleared Jan 04, 2019
Straumann PURE Ceramic Implant System
K180477 · DZE
Institut Straumann AG
Dental · 316d
Cleared Jan 04, 2019
BIO-C TEMP
K180199 · KIF
Angelus Industria DE Produtos...
Dental · 345d
Cleared Jan 03, 2019
Clear Image Aligners
K183643 · NXC
Specialty Appliance Works, Inc.
Dental · 8d
Cleared Jan 02, 2019
Signature Orthodontic System
K183542 · NJM
Signature Orthodontics
Dental · 13d
Cleared Jan 02, 2019
3M Filtek Universal Restorative
K183476 · EBF
3M Espe Dental Products
Dental · 16d
Cleared Dec 28, 2018
Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments
K181703 · DZE
Institut Straumann AG
Dental · 184d
Cleared Dec 28, 2018
CranioMaxillofacial Fixation (CMF) System - CMF Visionare
K180204 · JEY
Visionare, LLC
Dental · 338d
Cleared Dec 21, 2018
Neocis Guidance System
K182776 · PLV
Neocis, Inc.
Dental · 81d
Cleared Dec 21, 2018
JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White
K181331 · EBI
Juvora, Ltd.
Dental · 214d
Cleared Dec 21, 2018
DIO CAD/CAM Abutment
K181037 · NHA
Dio Corporation
Dental · 246d
Cleared Dec 18, 2018
Lucitone Denture Base Materials
K182422 · EBI
Dentsply Sirona
Dental · 103d
Cleared Dec 18, 2018
VINTAGE PRO
K181496 · EIH
Shofu Dental Corporation
Dental · 194d
Cleared Dec 18, 2018
Apex Locator, DPEX III
K181087 · LQY
Guilin Woodpecker Medical Instrument...
Dental · 237d
Cleared Dec 14, 2018
HyperFil-LV
K182296 · EBF
Parkell, Inc.
Dental · 112d
Cleared Dec 14, 2018
UV Active Implant System
K182194 · DZE
Dio Corporation
Dental · 122d
Cleared Dec 13, 2018
Erran Dental Zirconia
K182068 · EIH
Hangzhou Erran Technology Co., Ltd.
Dental · 134d
Cleared Dec 13, 2018
EVOLUX CAD/CAM PMMA BLOCKS
K182065 · EBG
Blue Dent Dental
Dental · 134d
Cleared Dec 13, 2018
PYRAMIDION Dental Implants and Prostheses
K180859 · DZE
Dentack Implants, Ltd.
Dental · 255d
Cleared Dec 12, 2018
On1 Universal Abutment
K181869 · NHA
Nobel Biocare AB
Dental · 153d
Cleared Dec 12, 2018
Harvest Dental Polymer Blocks
K180578 · EBG
Harvest Dental Products, LLC
Dental · 282d
Cleared Dec 07, 2018
Resin for Temporary Crown & Bridge
K180657 · EBG
Dentis Co., Ltd.
Dental · 269d
Cleared Dec 04, 2018
NobelZygoma 0°
K183069 · DZE
Nobel Biocare AB
Dental · 29d
Cleared Nov 29, 2018
Ceramic Denture Zirconia Ceramics Block
K181816 · EIH
Qinhuangdao Silide Ceramic Technology...
Dental · 143d