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
6097–6120 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Feb 28, 2002
GC FUJI LINING LC PASTE PAK
K020117 · EMA
GC America, Inc.
Dental · 45d
Cleared Feb 28, 2002
VENUS UNIVERSAL LIGHT CURING COMPOSITE
K020131 · EBF
Heraeus Kulzer, Inc.
Dental · 44d
Cleared Feb 27, 2002
PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE
K014059 · DYH
Pulpdent Corp.
Dental · 79d
Cleared Feb 22, 2002
BIOSORBFX O/M 2.0/2/4 SYSTEM
K011569 · JEY
Bionx Implants, Inc.
Dental · 277d
Cleared Feb 22, 2002
BOND-1 C & B
K013543 · KLE
Jeneric/Pentron, Inc.
Dental · 128d
Cleared Feb 22, 2002
NEOCALEX
K013993 · EIK
Stephen M Koral, Dmd
Dental · 80d
Cleared Feb 22, 2002
OPTIBOND SOLO PLUS 4
K014027 · KLE
Kerr Dental Materials Center
Dental · 78d
Cleared Feb 22, 2002
D.SIGN 84
K014042 · EJS
Ivoclar Vivadent, Inc.
Dental · 77d
Cleared Feb 22, 2002
DR. HAYS BITE GUARD
K014079 · MQC
Inventive Resources, Inc.
Dental · 73d
Cleared Feb 22, 2002
TEMPHASE
K020092 · EBG
Kerr Dental Materials Center
Dental · 43d
Cleared Feb 22, 2002
INION CPS BSSO SCREW
K020266 · HWC
Inion , Ltd.
Dental · 28d
Cleared Feb 22, 2002
LORENZ BLUE DEVICE
K020407 · MQN
Walter Lorenz Surgical, Inc.
Dental · 16d
Cleared Feb 20, 2002
UNIFIL BOND
K013997 · KLE
GC America, Inc.
Dental · 78d
Cleared Feb 20, 2002
SYNTHES CRANIAL PLATES
K020087 · JEY
Synthes (Usa)
Dental · 41d
Cleared Feb 19, 2002
PRIME-DENT HEMA DESENSITIZER
K013970 · EBF
Prime Dental Manufacturing, Inc.
Dental · 78d
Cleared Feb 19, 2002
JETPOLISHER
K014249 · KOJ
Deldent , Ltd.
Dental · 55d
Cleared Feb 19, 2002
JETSTREAM
K014252 · KOJ
Deldent , Ltd.
Dental · 55d
Cleared Feb 19, 2002
BONART ART-E1 ELECTROSURGERY UNIT
K020080 · EKZ
Diagnostic Data, Inc.
Dental · 41d
Cleared Feb 14, 2002
GINDA GUARD
K011239 · EBD
Cosmedent, Inc.
Dental · 297d
Cleared Feb 14, 2002
DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1)
K013542 · KLE
Jeneric/Pentron, Inc.
Dental · 120d
Cleared Feb 14, 2002
ENAMEL BONDING SYSTEM
K020050 · KLE
Rite-Dent Manufacturing Corp.
Dental · 38d
Cleared Feb 14, 2002
XERAFIT
K020062 · EJH
Metalor Technologies USA
Dental · 37d
Cleared Feb 12, 2002
WATERLASE MILLENNIUM
K013908 · MXF
Biolase Technology, Inc.
Dental · 78d
Cleared Feb 11, 2002
BRACE EZE
K020009 · EGD
Udent, Inc.
Dental · 40d