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
6433–6456 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jan 23, 2001
CAVEX TEMPORARY CEMENT
K003791 · EMA
Cavex Holland BV
Dental · 46d
Cleared Jan 23, 2001
MOLINA ORBITAL MALAR DISTRACTOR
K003883 · JEY
KLS-Martin L.P.
Dental · 39d
Cleared Jan 19, 2001
EDTA ROOT CANAL CLEANSER
K003422 · KJJ
Super Glide, Inc.
Dental · 77d
Cleared Jan 19, 2001
SPLINE DENTAL IMPLANT SYSTEM
K010073 · DZE
Sulzer Calcitek, Inc.
Dental · 10d
Cleared Jan 18, 2001
SYMPHONY GRAFT DELIVERY SYSTEM
K003286 · LYC
Depuyacromed
Dental · 90d
Cleared Jan 17, 2001
MAXILLARY DISTRACTOR
K003393 · JEY
Synthes (Usa)
Dental · 77d
Cleared Jan 16, 2001
PATTERN RESIN
K003817 · EBG
GC America, Inc.
Dental · 36d
Cleared Jan 12, 2001
2-PIECE POST AND CORE FOR THE B.A.S.I.C. DENTAL IMPLANT SYSTEM
K001259 · DZE
Basic Dental Implant Systems, Inc.
Dental · 268d
Cleared Jan 12, 2001
THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT SYSTEM
K003226 · DZE
Lifecore Biomedical, Inc.
Dental · 88d
Cleared Jan 11, 2001
AVANTE CURELIGHT
K003683 · EBZ
Jeneric/Pentron, Inc.
Dental · 43d
Cleared Jan 10, 2001
BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HERABOND, HERALOY G,...
K003603 · EJT
Jelenko Co.
Dental · 50d
Cleared Jan 09, 2001
SYNTHES (USA) RESORBABLE TACK SYSTEM
K000560 · JEY
Synthes (Usa)
Dental · 326d
Cleared Jan 09, 2001
AUROFILM NP
K003387 · EJH
Metalor Dental USA Corp.
Dental · 70d
Cleared Jan 09, 2001
UNIGRAFT
K003457 · LYC
Unicare Biomedical
Dental · 63d
Cleared Jan 09, 2001
RAPIDD HIGHSPEED DENTAL HANDPIECE
K003518 · EFB
Dentsply Intl.
Dental · 55d
Cleared Jan 08, 2001
STICK NET
K003334 · EBI
Stick Tech , Ltd.
Dental · 75d
Cleared Jan 08, 2001
COLLAGEN PERIODONTAL MEMBRANE
K003339 · NPL
Collagen Matrix, Inc.
Dental · 75d
Cleared Jan 04, 2001
ASTRA TECH IMPLANTS - DENTAL SYSTEM
K002513 · DZE
Astra Tech, Inc.
Dental · 142d
Cleared Jan 04, 2001
PALFIQUE ESTELITE LV
K002863 · EBF
Tokuyama America, Inc.
Dental · 113d
Cleared Jan 04, 2001
BIOEMG II AND BIOJVA
K003176 · KZM
Bio-Research Associates, Inc.
Dental · 85d
Cleared Jan 04, 2001
STICK
K003333 · EBI
Stick Tech , Ltd.
Dental · 71d
Cleared Jan 04, 2001
TEMP-BOND NE 2
K003658 · EMA
Sybron Dental Specialties, Inc.
Dental · 37d
Cleared Jan 03, 2001
BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH...
K003756 · JEY
Bionx Implants, Inc.
Dental · 28d
Cleared Jan 02, 2001
FLEXICAST
K003509 · EJH
American Dent-All, Inc.
Dental · 49d