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
1513–1536 of 12,659
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Sep 04, 2020
Neodent Implant System - GM Helix Implants 7.0
K201225 · DZE
Jjgc Industria E Comercio DE...
Dental · 121d
Cleared Sep 04, 2020
iCTmotor (WL-1)
K193341 · EBW
Dentium Co., Ltd.
Dental · 276d
Cleared Sep 03, 2020
Diamond Digital Sleep Orthotic (DDSO)
K202499 · LRK
Diamond Orthotic Laboratory
Dental · 3d
Cleared Sep 03, 2020
MIS Dental Implant System
K200102 · DZE
Dentsply Sirona
Dental · 230d
Cleared Sep 02, 2020
Oral-B Dry Mouth Oral Rinse
K201277 · LFD
The Procter & Gamble Company
Dental · 112d
Cleared Sep 02, 2020
LOCATOR R-Tx
K200827 · NHA
Ivory Super Holdco, Incp.
Dental · 156d
Cleared Sep 02, 2020
EtchPro Etching Gel
K200462 · KLE
Belport Company, Inc., Gingi-Pak
Dental · 190d
Cleared Sep 02, 2020
Simplant Digital Guide
K193405 · NDP
Dentsply Sirona
Dental · 268d
Cleared Sep 02, 2020
Bright Temporary C&B
K192830 · EBG
Dmp Dental Industry S.A.
Dental · 336d
Cleared Aug 28, 2020
Orthodontic Fixation Screw [Smart Anchor Miniscrew]
K191041 · OAT
Gni Co., Ltd.
Dental · 497d
Cleared Aug 27, 2020
Magicore System
K201981 · DZE
Innobiosurg Co., Ltd.
Dental · 42d
Cleared Aug 27, 2020
Oral-B iO Test Drive Power Brush Trial Program Kit
K200881 · JEQ
The Procter & Gamble Company
Dental · 147d
Cleared Aug 27, 2020
Nucleoss T6 Dental Implant System
K192062 · DZE
Sanlilar Tibbi Cihazlar Medikal Kimya...
Dental · 392d
Cleared Aug 26, 2020
Provicol QM Aesthetic
K201856 · EMA
Voco GmbH
Dental · 51d
Cleared Aug 25, 2020
Dental Handpiece
K192809 · EFA
Micro-Nx Co., Ltd.
Dental · 329d
Cleared Aug 24, 2020
MATRx plus
K200695 · MNR
Zephyr Sleep Technologies
Dental · 160d
Cleared Aug 21, 2020
U-Cem Premium & MAZIC Cem
K193260 · EMA
Vericom Co., Ltd.
Dental · 269d
Cleared Aug 20, 2020
Straumann TLX Implant System
K200586 · DZE
Institut Straumann AG
Dental · 167d
Cleared Aug 19, 2020
Straumann BLX Gold Abutments
K200597 · NHA
Straumann USA, LLC (On Behalf of...
Dental · 163d
Cleared Aug 19, 2020
Sirona Dental CAD/CAM System with InLab Software
K200191 · PNP
Dentsply Sirona
Dental · 205d
Cleared Aug 19, 2020
Omnichroma Flow
K193537 · EBF
Tokuyama Dental Corporation
Dental · 243d
Cleared Aug 18, 2020
Keystone Dental XL Dental Implant System
K201334 · DZE
Keystone Dental, Inc.
Dental · 90d
Cleared Aug 18, 2020
Coloring Liquid
K192723 · EIH
Aidite (Qinhuangdao) Technology Co.,...
Dental · 326d
Cleared Aug 18, 2020
BB Base 3D printing resin for denture base
K191591 · EBI
Enlighten Materials Co., Ltd.
Dental · 431d