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
1417–1440 of 12,659
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jan 28, 2021
GenesisZr UHT700 Zirconia
K201608 · EIH
United Dental Resources Corporation
Dental · 227d
Cleared Jan 23, 2021
Cytoplast Titanium-Reinforced PTFE Membranes
K201187 · NPK
Osteogenics Biomedical, Inc.
Dental · 267d
Cleared Jan 22, 2021
BRIUS Clear Aligners
K202792 · NXC
Brius Technologies, Inc.
Dental · 122d
Cleared Jan 22, 2021
Simply Iconic Implants
K201553 · DZE
Implant Direct Sybron Manufacturing, LLC
Dental · 226d
Cleared Jan 20, 2021
Dentsply Sirona Universal Spray Glazes
K202629 · EIH
Dentsply Sirona
Dental · 131d
Cleared Jan 19, 2021
R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose
K192913 · KLE
Imicryl Dis Malzemeleri Sanayi VE...
Dental · 462d
Cleared Jan 14, 2021
Vital Sleep
K201719 · LRK
The Snore Reliever Company, LLC
Dental · 205d
Cleared Jan 13, 2021
BEGO Semados® RS/RSX Implant System
K201700 · DZE
Bego Implant Systems GmbH & Co. KG
Dental · 205d
Cleared Jan 11, 2021
Striate+™
K201241 · NPL
Orthocell, Ltd.
Dental · 248d
Cleared Jan 08, 2021
OBS Anchorage Screw, Biokey Anchorage Screw
K202278 · OAT
Bomei Co, Ltd.
Dental · 150d
Cleared Jan 06, 2021
NEOLab Clear Aligners
K203339 · NXC
New England Ortho Lab, Inc.
Dental · 55d
Cleared Jan 05, 2021
ClearPath Aligner
K202857 · NXC
Clearpath Orthodontics, Ltd.
Dental · 99d
Cleared Dec 22, 2020
DenTek Fresh Protect Dental Guard
K202974 · OBR
Medtech Products, Inc.
Dental · 83d
Cleared Dec 22, 2020
Opallis, Opallis Flow
K201707 · EBF
Dentscare Ltda
Dental · 183d
Cleared Dec 22, 2020
Neodent Implant System - Zirconia Implant System
K201491 · DZE
Jjgc Industria E Comercio DE...
Dental · 201d
Cleared Dec 22, 2020
PlaniMax Orthodontic Software
K201036 · PNN
Choice Biotech, Inc.
Dental · 246d
Cleared Dec 22, 2020
iSMILE
K200908 · NXC
3D Diagnostix, Inc.
Dental · 260d
Cleared Dec 18, 2020
Blue Sky Bio CAD-CAM Abutments
K202026 · NHA
Blue Sky Bio, LLC
Dental · 149d
Cleared Dec 17, 2020
Blue Sky Bio TAD
K201919 · OAT
Blue Sky Bio, LLC
Dental · 160d
Cleared Dec 17, 2020
Aidite PMMA
K190217 · EBG
Aidite (Qinhuangdao) Technology Co.,...
Dental · 682d
Cleared Dec 16, 2020
CreoDent Solidex Customized Abutment and Screw
K202095 · NHA
Creodent Prosthetics, Ltd.
Dental · 140d
Cleared Dec 15, 2020
Neocis Guidance System (NGS) with Patient Splints (EPS)
K203401 · PLV
Neocis, Inc.
Dental · 26d
Cleared Dec 10, 2020
X-cera Pre-shaded Zirconia Blanks
K202673 · EIH
Dongguan Xiangtong Co., Ltd.
Dental · 86d
Cleared Dec 08, 2020
CARES Screw - Retained Bars and Bridges (SRBB)
K201711 · NHA
Medentika GmbH
Dental · 168d