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
4537–4560 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Nov 15, 2007
SPI CONTACT PLATFORM O 4.0 MM
K072933 · DZE
Thommen Medical AG
Dental · 30d
Cleared Nov 14, 2007
ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES
K072554 · EFB
Sable Industries, Inc.
Dental · 65d
Cleared Nov 09, 2007
T.B.R. ZIRCONNECT
K070935 · DZE
Sudimplant SA
Dental · 220d
Cleared Nov 09, 2007
PRIMACONNEX CAD/CAM ABUTMENT SYSTEM
K072241 · NHA
Lifecore Biomedical, Inc.
Dental · 88d
Cleared Nov 09, 2007
FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXITE PRO-GUARD
K072479 · EBI
Rapid Injection Systems Corp.
Dental · 66d
Cleared Nov 08, 2007
SM INTERNAL./EXTERNAL IMPLANT SYSTEM
K070569 · DZE
Dio Department Dsi, Inc.
Dental · 253d
Cleared Nov 08, 2007
EMULATE ADVANCED
K072245 · ELW
Cavex Holland BV
Dental · 87d
Cleared Nov 06, 2007
GS FIXTURE SYSTEM
K072896 · DZE
Osstem Implant Co., Ltd.
Dental · 26d
Cleared Nov 05, 2007
GUMEASE DENTAL MOUTHPIECE
K072082 · KKO
Biomedevice , Ltd.
Dental · 98d
Cleared Nov 05, 2007
JET DENTURE REPAIR POWDER MEHARRY 100,454 GRAMS, JET DENTURE REPAIR...
K072580 · EBI
Lang Dental Mfg. Co., Inc.
Dental · 53d
Cleared Oct 31, 2007
METOXIT CAM-BLANKS
K072569 · EIH
Metoxit AG
Dental · 49d
Cleared Oct 29, 2007
Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX
K062542 · DZE
Z-Systems AG
Dental · 425d
Cleared Oct 26, 2007
BONART MODEL ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS)
K071981 · ELC
Bonart Co., Ltd.
Dental · 100d
Cleared Oct 26, 2007
INFINITAS MINI-IMPLANT SYSTEM/GUIDANCE SYSTEM
K072086 · OAT
D B Orthodontics, Ltd.
Dental · 88d
Cleared Oct 26, 2007
ARTISTE SE FLOWABLE COMPOSITE, MODEL N280
K072545 · EBF
Pentron Clinical Technologies
Dental · 46d
Cleared Oct 23, 2007
OLYMPUS DENTAL IMPLANT SYSTEM
K071070 · DZE
Keystone Dental, Inc.
Dental · 190d
Cleared Oct 23, 2007
RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS
K072768 · DZE
Lifecore Biomedical, Inc.
Dental · 25d
Cleared Oct 19, 2007
ORAL NEUTRALIZER
K071617 · LFD
Oral Biotech
Dental · 128d
Cleared Oct 19, 2007
NEOSS VARIOUS TITANIUM ABUTMENTS
K071838 · NHA
Neoss, Ltd.
Dental · 106d
Cleared Oct 19, 2007
FLEX-STAR V
K072402 · EBI
Cmp Industries, LLC
Dental · 53d
Cleared Oct 18, 2007
PERFECT TISSUE CONTOURING SYSTEM II
K071632 · EKZ
Coltene/Whaledent, Inc.
Dental · 126d
Cleared Oct 18, 2007
HDC STERILE SPIDER SCREW
K071851 · DZE
Hdc S.R.L.
Dental · 105d
Cleared Oct 18, 2007
SYNOSS SYNTHETIC BONE GRAFT MATERIAL
K072397 · LYC
Collagen Matrix, Inc.
Dental · 52d
Cleared Oct 15, 2007
STRAUMANN P.004 RC GOLD ABUTMENT FOR BRIDGES
K071888 · NHA
Straumann USA
Dental · 98d