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
4201–4224 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jan 23, 2009
VALO, MODEL 5919
K083647 · EBZ
Ultradent Products, Inc.
Dental · 45d
Cleared Jan 22, 2009
CFS FLEXIBLE
K081537 · EBI
Comfort and Flexible Systems
Dental · 234d
Cleared Jan 22, 2009
CLEAR BRAVO
K083473 · EBC
Denali R&D Corporation
Dental · 59d
Cleared Jan 21, 2009
CARE3 PLUS
K081811 · EFB
Nakanishi, Inc.
Dental · 209d
Cleared Jan 21, 2009
IBOND TOTAL ETCH
K083652 · KLE
Heraeus Kulzer,GmbH
Dental · 43d
Cleared Jan 15, 2009
PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT
K082115 · EMA
S & C Polymer GmbH
Dental · 171d
Cleared Jan 15, 2009
A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98,...
K082716 · EFB
A-Dec, Inc.
Dental · 120d
Cleared Jan 14, 2009
SPECTRA-SYSTEM ABUTMENTS 2008
K081101 · NHA
Implant Direct, LLC
Dental · 272d
Cleared Jan 14, 2009
SWISSPLANT DENTAL IMPLANT SYSTEM
K081396 · NHA
Implant Direct, LLC
Dental · 240d
Cleared Jan 12, 2009
VOCO PROFLUORID L
K083036 · LBH
Voco GmbH
Dental · 90d
Cleared Jan 09, 2009
MASTERGRAFT RESORBABLE CERAMIC GRANULES
K082917 · LYC
Medtronic Sofamor Danek
Dental · 101d
Cleared Jan 09, 2009
PANASIL INITIAL CONTACT AND PANASIL TRAY
K083701 · ELW
Kettenbach GmbH & Co. KG
Dental · 25d
Cleared Jan 07, 2009
A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT
K082827 · EFB
A-Dec, Inc.
Dental · 104d
Cleared Jan 06, 2009
IROOT BP, MODEL IRBP 4609
K082943 · KIF
Innovative Bioceramix, Inc.
Dental · 96d
Cleared Dec 30, 2008
BITTAR ZIRCONIA BLOCKS
K082652 · EIH
Bittar Zirconia Block, LLC
Dental · 109d
Cleared Dec 23, 2008
ZIMMER ANGLED CONTOUR ZIRCONIA ABUTMENT
K083474 · NHA
Zimmer Dental, Inc.
Dental · 29d
Cleared Dec 22, 2008
ENDOSSEOUS DENTAL IMPLANT SYSTEM
K082651 · DZE
Southern Implants, Inc.
Dental · 101d
Cleared Dec 19, 2008
ADIN DENTAL IMPLANTS SYSTEM
K081751 · DZE
Adin Dental Implants System, Ltd.
Dental · 183d
Cleared Dec 19, 2008
ZIMMER DENTAL TAPERED SWISSPLUS IMPLANTS
K082639 · DZE
Zimmer Dental, Inc.
Dental · 100d
Cleared Dec 17, 2008
MIS CREST WIDENER
K080458 · MQN
Mis - Implant Technologies , Ltd.
Dental · 301d
Cleared Dec 17, 2008
INVISALIGN SYSTEM
K081960 · NXC
Align Technology
Dental · 161d
Cleared Dec 17, 2008
HEMOSTASYL PASTE
K082116 · MVL
Satelec
Dental · 142d
Cleared Dec 17, 2008
PERMA FIBER,MODEL 441
K082180 · EBI
Angelus Industria DE Productos...
Dental · 138d
Cleared Dec 17, 2008
A-DEC 334/335 DELIVERY SYSTEM
K082985 · EIA
A-Dec, Inc.
Dental · 71d