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
1585–1608 of 12,659
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared May 29, 2020
Dental Zirconia Blocks
K192262 · EIH
De Corematrix Co., Ltd.
Dental · 282d
Cleared May 26, 2020
DiaPlus
K192392 · KLE
DiaDent Group International
Dental · 266d
Cleared May 26, 2020
High-speed air turbine handpiece / Low-speed air turbine handpiece
K181691 · EFB
Foshan Wenjian Medical Instrument...
Dental · 699d
Cleared May 21, 2020
X-Guide® Surgical Navigation System
K200662 · PLV
X-Nav Technologies, LLC
Dental · 69d
Cleared May 18, 2020
VarseoSmile Temp
K193553 · EBG
Bego Bremer Goldschlagerei Wilh....
Dental · 150d
Cleared May 18, 2020
UF(II) Bar holder abutment
K193404 · NHA
Dio Corporation
Dental · 164d
Cleared May 14, 2020
VITA Ambria
K193436 · EIH
Vita Zahnfabrik GmbH H Rauter & CO
Dental · 155d
Cleared May 14, 2020
S.I.N. Dental Implant System
K193096 · DZE
S.I.N. ? Sistema DE Implante Nacional...
Dental · 189d
Cleared May 13, 2020
Purzir Dental Zirconia
K193055 · EIH
3DBiocad
Dental · 194d
Cleared May 11, 2020
Arcad SmileStudio and Aligner System
K192244 · NXC
Arcadlab
Dental · 266d
Cleared May 08, 2020
Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)
K200348 · PLV
Neocis, Inc.
Dental · 86d
Cleared May 08, 2020
Custom Legacy and Custom InterActive Titanium Abutments
K192218 · NHA
Implant Direct Sybron Manufacturing, LLC
Dental · 267d
Cleared May 07, 2020
ZAGA Zygomatic System
K192651 · DZE
Southern Implants (Pty), Ltd.
Dental · 226d
Cleared May 06, 2020
CharmFil
K193496 · EBF
Dentkist, Inc.
Dental · 141d
Cleared May 06, 2020
Aerodentis System
K192069 · NXC
Dror Orthodesign
Dental · 279d
Cleared May 05, 2020
Lascod Impression Materials
K201184 · ELW
Lascod Spa
Dental · 4d
Cleared May 05, 2020
AA temp temporary restoration 3D printing photoreactive resin
K191590 · EBG
Enlighten Materials Co., Ltd.
Dental · 326d
Cleared Apr 28, 2020
Implantswiss Dental Implant System and Implantswiss Dental Abutment System
K200867 · DZE
Novodent SA
Dental · 27d
Cleared Apr 28, 2020
Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants
K193592 · DZE
Jjgc Industria E Comercio DE...
Dental · 127d
Cleared Apr 28, 2020
Magicore II System
K192197 · DZE
Innobiosurg Co., Ltd.
Dental · 259d
Cleared Apr 27, 2020
GlassLok Kits, GlassLok Powder, GlassLok Liquid
K193388 · DYH
Reliance Orthodontic Products, Inc.
Dental · 143d
Cleared Apr 24, 2020
Zircos-Com
K190139 · EBF
Bioden Co., Ltd.
Dental · 451d
Cleared Apr 23, 2020
NemoFAB
K192475 · LLZ
Software Nemotec S.L.
Dental · 226d
Cleared Apr 23, 2020
U-Aligner
K191308 · NXC
Universal Orthodontic Laboratory, Inc.
Dental · 345d