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
5545–5568 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jan 23, 2004
ONE COAT SE BOND
K033760 · KLE
Coltene/Whaledent, Inc.
Dental · 52d
Cleared Jan 22, 2004
MATCH MASTER LOW FUSION PORCELAIN
K024252 · EIH
Davis Schottlander & Davis, Ltd.
Dental · 395d
Cleared Jan 21, 2004
VARIFLEX
K033632 · EBI
Great Lakes Orthodontics, Ltd.
Dental · 63d
Cleared Jan 16, 2004
LUXAFORM PLUS
K033227 · EBG
Dmg USA, Inc.
Dental · 102d
Cleared Jan 16, 2004
BISBLOCK
K033521 · EJK
Bisco, Inc.
Dental · 70d
Cleared Jan 16, 2004
DIAPEX
K033585 · KIF
Bisco, Inc.
Dental · 64d
Cleared Jan 16, 2004
ARTIC
K033628 · ELM
Heraeus Kulzer, Inc.
Dental · 58d
Cleared Jan 15, 2004
GOLD DENTAL CASTING ALLOYS
K033279 · EJT
Bego U.S.A.
Dental · 97d
Cleared Jan 15, 2004
LEXATITE QUICK ACRYLIC
K033432 · EBG
Imtec Corp.
Dental · 79d
Cleared Jan 15, 2004
TESCERA U-BAR AND BARRELS
K033472 · EBI
Bisco, Inc.
Dental · 73d
Cleared Jan 15, 2004
KLS-MARTIN ORTHO ANCHORAGE SYSTEM
K033483 · DZE
KLS-Martin L.P.
Dental · 72d
Cleared Jan 15, 2004
PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER
K033675 · KOJ
Sirona Dental Systems GmbH
Dental · 52d
Cleared Jan 15, 2004
CONCEPT HP ADD-ON
K033773 · EBF
Ivoclar Vivadent, AG
Dental · 43d
Cleared Jan 15, 2004
BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGEN
K033815 · NPM
Geistlich-Pharma
Dental · 37d
Cleared Jan 12, 2004
ENDOPURE ROOT CANAL CLEANSER
K032361 · KJJ
Dentsply Intl.
Dental · 165d
Cleared Jan 09, 2004
PREPAIR
K033215 · KOJ
Danville Materials, Inc.
Dental · 98d
Cleared Jan 07, 2004
OSTEOMED ORTHODONTIC SCREW SYSTEM
K031936 · DZE
Osteomed LP
Dental · 198d
Cleared Jan 07, 2004
PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES
K033449 · EJR
Professional Dental Technologies...
Dental · 70d
Cleared Jan 07, 2004
MODIFICATION TO ITI DENTAL IMPLANT SYSTEM
K033922 · DZE
Institut Straumann AG
Dental · 20d
Cleared Dec 30, 2003
VERASOFT ES
K033356 · EJH
Aalba Dent, Inc.
Dental · 101d
Cleared Dec 30, 2003
VENUS FLOW
K033665 · EBF
Heraeus Kulzer, Inc.
Dental · 39d
Cleared Dec 23, 2003
INTRA-LOCK HYDROXYAPATITE COATED IMPLANTS
K031322 · DZE
Intra-Lock International
Dental · 242d
Cleared Dec 23, 2003
DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST
K033045 · EJH
American Green Dent. Mfg, Inc.
Dental · 85d
Cleared Dec 22, 2003
CERABIEN ZR
K031968 · EIH
Noritake Co., Inc.
Dental · 179d