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
6481–6504 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Nov 28, 2000
SELF ETCH BONDING PRIMER
K003011 · KLE
Jeneric/Pentron, Inc.
Dental · 63d
Cleared Nov 28, 2000
RENEW LS-2
K003361 · EBF
Bisco, Inc.
Dental · 32d
Cleared Nov 28, 2000
PROCAD ADD-ON
K003373 · EIH
Ivoclar North America, Inc.
Dental · 29d
Cleared Nov 21, 2000
RENEW LS-1
K003317 · EBF
Bisco, Inc.
Dental · 28d
Cleared Nov 17, 2000
RACE ENDODONTIC FILE
K002709 · EFA
Amc General, Inc.
Dental · 79d
Cleared Nov 17, 2000
GALAXY
K003007 · EJT
Sterngold
Dental · 52d
Cleared Nov 16, 2000
NEWGEN SYSTEM
K002619 · JEY
Stryker Instruments
Dental · 85d
Cleared Nov 16, 2000
SURESMILE SYSTEM
K002620 · EIA
Orametrix, Inc.
Dental · 85d
Cleared Nov 16, 2000
SYNTHES 1.5MM TI BROW LIFT SCREW
K002935 · DZL
Synthes (Usa)
Dental · 56d
Cleared Nov 16, 2000
HERACERAM
K002993 · EIH
J.F. Jelenko & Co., Inc.
Dental · 52d
Cleared Nov 15, 2000
SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010
K002843 · EMA
Sultan Chemists, Inc.
Dental · 64d
Cleared Nov 15, 2000
SOLOBOND PLUS
K003153 · KLE
Voco GmbH
Dental · 36d
Cleared Nov 13, 2000
SPARTAN MTS
K002521 · ELC
Spartan Marketing Group
Dental · 90d
Cleared Nov 09, 2000
REPLACE TPS COATED IMPLANTS
K002475 · DZE
Nobel Biocare Uas, Inc.
Dental · 90d
Cleared Nov 09, 2000
CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS)
K002693 · EBL
Cbs Intl. B.V.
Dental · 72d
Cleared Nov 08, 2000
CERAM-PRIME
K002502 · KLE
S & C Polymer GmbH
Dental · 86d
Cleared Nov 06, 2000
WILLI GELLER CREATION AND LF PORCELAIN
K002904 · EIH
Jensen Industries, Inc.
Dental · 49d
Cleared Nov 06, 2000
MODEL K7 EVALUATION DEVICE
K003287 · KZM
Myotronics-Noromed, Inc.
Dental · 17d
Cleared Nov 02, 2000
R&D PROJECT DW271#11A
K002872 · EJT
Ivoclar North America, Inc.
Dental · 49d
Cleared Nov 01, 2000
ITI DENTAL IMPLANT SYSTEM MONOTYPE IMPLANT
K002374 · DZE
Straumann USA
Dental · 89d
Cleared Oct 31, 2000
ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY
K002808 · EJJ
Nordiska Dental AB
Dental · 53d
Cleared Oct 31, 2000
ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY
K002810 · EJJ
Nordiska Dental AB
Dental · 53d
Cleared Oct 31, 2000
ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOY
K002811 · EJJ
Nordiska Dental AB
Dental · 53d
Cleared Oct 30, 2000
SWISSPLUS IMPLANT SYSTEM, MODEL SPWB 8,10,12,14/OPH20/SMPR, SPB...
K002188 · DZE
Core-Vent Corp.
Dental · 102d