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
5185–5208 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jun 23, 2005
JET BLUE BITE
K051243 · ELW
Coltene/Whaledent AG
Dental · 41d
Cleared Jun 21, 2005
CAVEX ORTHOTRACE
K051207 · ELW
Cavex Holland BV
Dental · 41d
Cleared Jun 21, 2005
SPI DENTAL IMPLANT
K051502 · DZE
Thommen Medical AG
Dental · 14d
Cleared Jun 15, 2005
MEDICON IMF-ORION SCREWS
K050478 · DZE
Medicon EG
Dental · 111d
Cleared Jun 15, 2005
SET
K051008 · EMA
Southern Dental Industries, Ltd.
Dental · 56d
Cleared Jun 15, 2005
GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE,...
K051267 · NPK
W.L. Gore & Associates, Inc.
Dental · 30d
Cleared Jun 14, 2005
FRIADENT ESTHETICAP
K050208 · NHA
Dentsply International
Dental · 137d
Cleared Jun 14, 2005
CRANION CRANIAL FIXATION SYSTEM
K051293 · JEY
Ceremed , Inc.
Dental · 27d
Cleared Jun 10, 2005
RIVA PROTECT
K050871 · EBC
Southern Dental Industries, Inc.
Dental · 65d
Cleared Jun 08, 2005
PIEZOSURGERY DEVICE
K043408 · DZI
Piezosurgery S.R.L.
Dental · 180d
Cleared Jun 08, 2005
NOBELSPEEDY IMPLANTS
K050406 · DZE
Nobel Biocare AB
Dental · 111d
Cleared Jun 08, 2005
PREVAIL DENTAL IMPLANTS
K051189 · DZE
Implant Innovations, Inc.
Dental · 29d
Cleared Jun 07, 2005
PROTECT TOOTH DESENSITIZER
K050486 · LBH
Sunstar Butler
Dental · 102d
Cleared Jun 07, 2005
IBOND NEXT GENERATION
K051006 · KLE
Heraeus Kulzer,GmbH
Dental · 48d
Cleared Jun 03, 2005
RIVA LIGHT CURE
K050870 · EMA
Southern Dental Industries, Inc.
Dental · 58d
Cleared Jun 01, 2005
ORLUS MINI SCREW
K050568 · DZE
Ortholution Co., Ltd.
Dental · 89d
Cleared May 27, 2005
RESO-PAC PERIODONTAL DRESSING
K050658 · EMA
Hager Worldwide, Inc.
Dental · 74d
Cleared May 27, 2005
INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM, 40 AND 64 HOLE PLATES,...
K051341 · JEY
Inion , Ltd.
Dental · 4d
Cleared May 26, 2005
JEIL BONE FIXATION SYSTEM
K050669 · JEY
Jeil Medical Corporation
Dental · 72d
Cleared May 25, 2005
BLUELEX
K051203 · EBZ
Monitex Industrial Co., Ltd.
Dental · 14d
Cleared May 23, 2005
MC6A
K050735 · EKZ
Macan Engineering Co.
Dental · 63d
Cleared May 19, 2005
TIUNITE IMPLANTS
K050705 · DZE
Nobel Biocare AB
Dental · 62d
Cleared May 18, 2005
SYNTHES CARNIOFACIAL PLATE AND SCREW SYSTEM
K050608 · JEY
Synthes (Usa)
Dental · 69d
Cleared May 11, 2005
CZR PRESS LF STAINS
K050920 · EIH
Noritake Co., Inc.
Dental · 29d