FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Dental ×
12,611 results
1369–1392 of 12,611
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