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
3337–3360 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jun 29, 2012
TEK USA E-GENERATOR INTEGRATED LED HANDPIECE (HIGH & LOW SPEED AIR TURBNINE...
K120218 · EFB
Palm Beach Dental Supply D/B/A Tek USA
Dental · 156d
Cleared Jun 29, 2012
BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT...
K113512 · JEY
Biomet Microfixation
Dental · 214d
Cleared Jun 27, 2012
DR GREENBURGS HYBRID VACUUM
K120372 · LRK
Always More Marketing, Inc.
Dental · 142d
Cleared Jun 27, 2012
DR GREENBURGS HYBRID ACRYLIC
K120371 · LRK
Always More Marketing, Inc.
Dental · 142d
Cleared Jun 27, 2012
GAM-200
K120243 · EMA
GC America, Inc.
Dental · 152d
Cleared Jun 27, 2012
ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD
K113326 · OBR
Oralabs, Inc.
Dental · 230d
Cleared Jun 25, 2012
IPS E.MAX PRESS MULTI
K120134 · EIH
Ivoclar Vivadent, AG
Dental · 160d
Cleared Jun 21, 2012
BEAM BRUSH/BEAM APP
K121165 · EFW
Beam Technologies, LLC
Dental · 65d
Cleared Jun 20, 2012
DRFP PROPOINTS, PROPOINTS 4%, PROPOINTS 6%, PROPOINTS PT, PROPOINTS S
K120048 · KIF
Drfp , Ltd.
Dental · 166d
Cleared Jun 20, 2012
TI-MAX X450
K112024 · EFB
Nakanishi, Inc.
Dental · 341d
Cleared Jun 19, 2012
I-ROOT 100
K112508 · LQY
S-Denti Co., Ltd.
Dental · 294d
Cleared Jun 18, 2012
CMI IMPLANT IS II ACTIVE
K120503 · DZE
Neobiotech Co., Ltd.
Dental · 118d
Cleared Jun 18, 2012
BEAUTICEM SA
K120159 · EMA
Shofu Dental Corporation
Dental · 151d
Cleared Jun 14, 2012
ULTRASONIC SURGERY MACHINE
K113152 · DZI
Dmetec.Co., Ltd.
Dental · 233d
Cleared Jun 12, 2012
DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT
K120695 · EMB
Dentist IN A Box Pty., Ltd.
Dental · 97d
Cleared Jun 11, 2012
PURESLEEP
K113022 · LRK
Sleep Science Partners, Inc.
Dental · 244d
Cleared Jun 08, 2012
TUFF-TEMP 2.0
K120784 · EBG
Pulpdent Corporation
Dental · 85d
Cleared Jun 08, 2012
TELIO CS CEM IMPLANT
K120432 · EMA
Ivoclar Vivadent, AG
Dental · 116d
Cleared Jun 06, 2012
PROSOFT
K121318 · EBP
Perma Laboratories
Dental · 35d
Cleared Jun 06, 2012
BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM
K121131 · DZE
Straumann USA
Dental · 54d
Cleared Jun 06, 2012
ZIRCONIA BLANKS (ZIRCOSTAR)
K120852 · EIH
Kerox, Ltd.
Dental · 77d
Cleared Jun 06, 2012
AIR LIFT/XEROSTOM ARTIFICIAL SALIVA
K120552 · LFD
Biocosmetics Laboratories
Dental · 104d
Cleared Jun 06, 2012
LOCATOR OVERDENTURE IMPLANT SYSTEM
K120198 · DZE
Zest Anchors, LLC
Dental · 135d
Cleared Jun 06, 2012
MILLENIUM ANTI-SNORING DEVICE
K112627 · LQZ
Millenium Dental Laboratory, Inc.
Dental · 271d