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
4321–4344 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Aug 07, 2008
APROXI 1100 AND 4000 SERIES DENTAL INLAYS
K073047 · EBF
Aproxi Aps
Dental · 283d
Cleared Aug 07, 2008
TCM ENDO 20
K081191 · EKX
NOUVAG AG
Dental · 101d
Cleared Aug 06, 2008
TRICOS A RESORBABLE SUBSTITUTE
K081721 · LYC
Baxter Healthcare Corp
Dental · 49d
Cleared Aug 06, 2008
KETTOSIL AND SILGINAT
K082157 · ELW
Kettenbach GmbH & Co. KG
Dental · 6d
Cleared Aug 04, 2008
RADIANCE
K080749 · NJM
American Orthodontics
Dental · 140d
Cleared Aug 04, 2008
TEMPLATE AND COUNTER-FIT
K081017 · ELW
Clinician'S Choice Dental Products, Inc.
Dental · 117d
Cleared Jul 29, 2008
SURGICAL HANDPIECES, MIKRO SAW HANDPIECES
K080939 · KMW
W&H Dentalwerk Buermoos GmbH
Dental · 117d
Cleared Jul 28, 2008
PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY
K080220 · DZI
Italia Medica S.R.L.
Dental · 181d
Cleared Jul 28, 2008
OSFERION D
K081561 · LYC
Olympus Terumo Biomaterials Corporation
Dental · 55d
Cleared Jul 28, 2008
CLEARFIL SA CEMENT
K081583 · EMA
Kuraray Medical, Inc.
Dental · 53d
Cleared Jul 24, 2008
VOCO PROFLUORID VARNISH
K080814 · LBH
Voco GmbH
Dental · 122d
Cleared Jul 22, 2008
ACCUFRAME
K081157 · NHA
Cagenix, Inc.
Dental · 90d
Cleared Jul 21, 2008
SONICWELD RX (RESORB-X)
K080862 · JEY
KLS-Martin L.P.
Dental · 116d
Cleared Jul 21, 2008
CAM STRUCTSURE PRECISION MILLED BARS
K080864 · NHA
Biomet 3i, Inc.
Dental · 115d
Cleared Jul 18, 2008
SIALO DRAIN
K072334 · OAJ
Sialo Technology, Ltd.
Dental · 333d
Cleared Jul 18, 2008
PROGENIX PLUS
K081950 · NUN
Medtronic Sofamor Danek, Inc.
Dental · 9d
Cleared Jul 17, 2008
HG II FIXTURE SYSTEM
K080744 · DZE
Osstem Implant Co., Ltd.
Dental · 122d
Cleared Jul 16, 2008
LION SE ONE STEP ORTHODONTIC ADHESIVE
K080445 · DYH
Classone Orthodontics, Inc.
Dental · 148d
Cleared Jul 15, 2008
SCREWINDIRECT DENTAL IMPLANTS
K080633 · DZE
Implant Direct, LLC
Dental · 132d
Cleared Jul 15, 2008
NT/IT SYSTEM
K081078 · DZE
Osstem Implant Co., Ltd.
Dental · 90d
Cleared Jul 10, 2008
VARIOSURG
K073678 · DZI
Nakanishi, Inc.
Dental · 195d
Cleared Jul 10, 2008
ULTRACAPS S
K081273 · OIV
Sdi , Ltd.
Dental · 66d
Cleared Jul 10, 2008
IMPROVED COMFORT-FIT NIGHTGUARD
K081669 · OBR
Den Tek Oral Care, Inc.
Dental · 27d
Cleared Jul 03, 2008
KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODELS ESSENTIAL CONE (EC),...
K080224 · DZE
SOADCO, S.L.
Dental · 156d