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
6265–6288 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Sep 04, 2001
DC - CRISTAL
K011674 · EIH
Austenal, Inc.
Dental · 97d
Cleared Sep 04, 2001
NOVEL PRINT CYAN ALGINATES
K011785 · ELW
Manufacturera Dental Continental
Dental · 88d
Cleared Sep 04, 2001
TOKUYAMA M-BOND
K011854 · EMA
Tokuyama America, Inc.
Dental · 83d
Cleared Sep 04, 2001
EXTRUDE MODIFIED
K012405 · ELW
Sybron Dental Specialties, Inc.
Dental · 36d
Cleared Sep 04, 2001
MODIFICATION TO CLEARFIL PHOTO BOND
K012432 · KLE
Kuraray Medical, Inc.
Dental · 35d
Cleared Sep 04, 2001
MODIFICATION TO ALLOY PRIMER
K012436 · KLE
Kuraray Medical, Inc.
Dental · 35d
Cleared Aug 30, 2001
OPTIBOND 2
K012322 · KLE
Sybron Dental Specialties, Inc.
Dental · 38d
Cleared Aug 30, 2001
TRANSLUX ENERGY
K012341 · EBZ
Heraeus Kulzer, Inc.
Dental · 37d
Cleared Aug 27, 2001
GPW-SF
K011659 · EJT
Gateway Alloys, Inc.
Dental · 90d
Cleared Aug 27, 2001
CONCORD 88
K011661 · EJT
Gateway Alloys, Inc.
Dental · 90d
Cleared Aug 27, 2001
ERIS LAYERING MATERIALS
K012174 · EIH
Ivoclar North America, Inc.
Dental · 46d
Cleared Aug 27, 2001
POINT 4 FLOWABLE
K012321 · EBF
Sybron Dental Specialties, Inc.
Dental · 35d
Cleared Aug 23, 2001
STRAUMANN GBR SYSTEM
K011698 · JEY
Institut Straumann AG
Dental · 83d
Cleared Aug 23, 2001
HI-WAVE
K011762 · EBI
Denplus, Inc.
Dental · 77d
Cleared Aug 23, 2001
AVANTE MICRO CRYSTAL SYSTEM
K012231 · EIH
Jeneric/Pentron, Inc.
Dental · 38d
Cleared Aug 23, 2001
LUXACORE/LUXACORE DUAL
K012307 · EBF
Dmg USA, Inc.
Dental · 31d
Cleared Aug 23, 2001
PERMACEM / PERMACEM DUAL
K012316 · EMA
Dmg USA, Inc.
Dental · 31d
Cleared Aug 22, 2001
JEL-20
K012303 · EJS
J.F. Jelenko & Co., Inc.
Dental · 33d
Cleared Aug 22, 2001
ITI DENTAL IMPLANT SYSTEM
K012757 · DZE
Straumann USA
Dental · 5d
Cleared Aug 20, 2001
CERCON CERAM
K011333 · EIH
Degussa - Ney Dental, Inc.
Dental · 110d
Cleared Aug 17, 2001
ITI DENTAL IMPLANT SYSTEM
K003552 · DZE
Institut Straumann SA
Dental · 273d
Cleared Aug 16, 2001
VERTEX SEALAND L/C ORTHODONTIC SEALANT
K010547 · KLE
Apex Dental Materials, Inc.
Dental · 174d
Cleared Aug 16, 2001
HELIOSEAL CLEAR CHROMA
K011491 · EBC
Ivoclar North America, Inc.
Dental · 93d
Cleared Aug 16, 2001
FUTURA TOPCAP NON GAMMA-2
K011801 · EJJ
Ab Ardent
Dental · 69d