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
1993–2016 of 12,659
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Sep 11, 2018
TruBase S
K171532 · NHA
Truabutment, Inc.
Dental · 474d
Cleared Sep 06, 2018
Provata Implant System
K180465 · DZE
Southern Implants (Pty), Ltd.
Dental · 197d
Cleared Sep 02, 2018
Upcera Glaze Paste, Glaze Powder, and Glaze Liquid
K181167 · EIH
Liaoning Upcera Co., Ltd.
Dental · 123d
Cleared Aug 31, 2018
myTAP2
K181482 · LRK
Airway Management, Inc.
Dental · 87d
Cleared Aug 31, 2018
BIO-C REPAIR
K180185 · KIF
Angelus Industria DE Produtos...
Dental · 220d
Cleared Aug 30, 2018
Neodent Implant System – GM Line
K180536 · DZE
Jjgc Industria E Comercio DE...
Dental · 183d
Cleared Aug 30, 2018
Anchor plate
K173623 · OAT
Biomaterials Korea, Inc.
Dental · 279d
Cleared Aug 29, 2018
Meta P&Bond
K180802 · KLE
Meta Biomed Co., Ltd.
Dental · 154d
Cleared Aug 23, 2018
Smylic Invisible Clear Aligners
K173784 · NXC
Smylio, Inc.
Dental · 253d
Cleared Aug 23, 2018
Z-CAD smile
K170050 · EIH
Metoxit AG
Dental · 595d
Not Cleared Aug 23, 2018
MATRx plus
DEN170090 · QCJ
Zephyr Sleep Technologies
Dental · 245d
Cleared Aug 22, 2018
GrandioSO x-tra
K181312 · EBF
Voco GmbH
Dental · 97d
Cleared Aug 20, 2018
Young INFINITY Cordless Handpiece System
K171377 · EKX
Young Dental Manufacturing Co. 1, LLC
Dental · 467d
Cleared Aug 17, 2018
Forest Dental Unit
K173608 · EIA
Forest Dental Products, Inc.
Dental · 269d
Cleared Aug 17, 2018
OsteoReady Dental Implant System
K173575 · DZE
Osteoready, LLC
Dental · 270d
Cleared Aug 17, 2018
BTI Dental Implant System UnicCa
K173257 · DZE
B.T.I. Biotechnology Institute, Sl.
Dental · 311d
Cleared Aug 15, 2018
BRILLIANT Crios
K181500 · EBF
Coltene/Whaledent AG
Dental · 69d
Cleared Aug 15, 2018
InterActive SMARTBase Abutments
K181359 · NHA
Implant Direct Sybron Manufacturing, LLC
Dental · 85d
Cleared Aug 13, 2018
KLS Martin Individual Patient Solutions
K180962 · JEY
KLS-Martin L.P.
Dental · 123d
Cleared Aug 09, 2018
MyPlant II Implant System
K173819 · DZE
Hager& Meisinger GmbH
Dental · 234d
Cleared Aug 08, 2018
UNIQA Dental Implants System
K180598 · DZE
Uniqa Dental, Ltd.
Dental · 154d
Cleared Aug 01, 2018
VITA YZ ST and VITA YZ XT
K180703 · EIH
Vita Zahnfabrik H.Rauter GmbH & Co.
Dental · 135d
Cleared Jul 27, 2018
Voutia™
K173808 · LFD
Jeffrey Ward Cash, Dds
Dental · 224d
Cleared Jul 24, 2018
S-mini active Fixture
K181178 · DZE
Neobiotech Co., Ltd.
Dental · 83d