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
6937–6960 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Mar 04, 1999
MONOPAQUE
K990315 · EBF
Ivoclar North America, Inc.
Dental · 31d
Cleared Mar 03, 1999
HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025
K990306 · EBC
Kay See Dental Mfg. Co.
Dental · 30d
Cleared Mar 01, 1999
PROVISIONAL DENTAL IMPLANT SYSTEM
K984287 · DZE
Nobel Biocare Uas, Inc.
Dental · 90d
Cleared Mar 01, 1999
D-SIGN V (R&D PROJECT DW267#17)
K990182 · EJH
Ivoclar North America, Inc.
Dental · 40d
Cleared Mar 01, 1999
D-SIGN VI (R&D PROJECT DW266#9)
K990235 · EJH
Ivoclar North America, Inc.
Dental · 35d
Cleared Feb 26, 1999
ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000
K984503 · KLE
Wallace A. Erickson & Co.
Dental · 70d
Cleared Feb 25, 1999
ELIPAR TRILIGHT
K984247 · EBZ
Espe Dental AG
Dental · 90d
Cleared Feb 25, 1999
GC UNIFAST TRAD
K984365 · EBI
GC America, Inc.
Dental · 80d
Cleared Feb 25, 1999
GLUMA ONE BOND
K990143 · KLE
Heraeus Kulzer, Inc.
Dental · 37d
Cleared Feb 25, 1999
HYDRO-CAST VERSA-TEMP NON-EUGENOL PROVISIONAL CEMENT, MODEL 70010
K990155 · EMA
Kay See Dental Mfg. Co.
Dental · 37d
Cleared Feb 25, 1999
ENDO ANALYZER, MODEL 8005, MODIFIED
K990225 · EAT
Sybron Dental Specialties, Inc.
Dental · 31d
Cleared Feb 25, 1999
SOLO PLUS ORTHO
K990252 · DYH
Sybron Dental Specialties, Inc.
Dental · 29d
Cleared Feb 24, 1999
FUSICRYL
K984467 · EBI
Micro Dental Laboratories
Dental · 70d
Cleared Feb 24, 1999
MODIFICATION OF MILLENNIUM
K990219 · MXF
Biolase Technology, Inc.
Dental · 33d
Cleared Feb 23, 1999
ORL-E-92 SURGICAL DRILL SYSTEM
K984244 · EFB
Bien Air USA, Inc.
Dental · 88d
Cleared Feb 18, 1999
WIDE BODY ABUTMENTS
K984198 · DZE
Vident
Dental · 86d
Cleared Feb 18, 1999
A-SOFT RELINER
K984483 · EBI
S & C Polymer GmbH
Dental · 64d
Cleared Feb 17, 1999
BIOSORBFX 2.0/2.4 ORTHOGNATHIC AND MANDIBULAR FIXATION SYSTEM
K982721 · JEY
Bionx Implants, Inc.
Dental · 197d
Cleared Feb 12, 1999
SCI-PHARM DFV VARNISH
K982915 · LBH
Scientific Pharmaceuticals, Inc.
Dental · 177d
Cleared Feb 12, 1999
NORIAN PERIODONTAL/DENTAL CEMENT (PDC)
K983104 · LYC
Norian Corp.
Dental · 161d
Cleared Feb 12, 1999
NATURA DENTURE TEETH
K984134 · ELM
Davis Schottlander & Davis, Ltd.
Dental · 86d
Cleared Feb 12, 1999
D-SIGN III (R&D PROJECT DW264#7)
K990077 · EJS
Ivoclar North America, Inc.
Dental · 32d
Cleared Feb 12, 1999
D-SIGN IV (R&D PROJECT DW265#37)
K990078 · EJS
Ivoclar North America, Inc.
Dental · 32d
Cleared Feb 10, 1999
INNOVA TELESCOPIC DISTRACTOR
K984117 · MQN
Innova Corp.
Dental · 85d