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
10009–10032 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared May 29, 1990
COPAL VARNISH
K901049 · LBH
Pulpdent Corp.
Dental · 85d
Cleared May 29, 1990
PRELUDE (TEMPORARY CROWN AND BRIDGE CEMENT)
K901077 · EBG
Scientific Pharmaceuticals, Inc.
Dental · 83d
Cleared May 29, 1990
SPARTAN PLUS
K901098 · EJT
Ivoclar North America, Inc.
Dental · 83d
Cleared May 25, 1990
EOS INLAY MATERIAL
K896469 · EBF
Ivoclar North America, Inc.
Dental · 193d
Cleared May 25, 1990
UNIVERSUM
K900946 · LBH
Scientific Pharmaceuticals, Inc.
Dental · 85d
Cleared May 22, 1990
FLUOR-I-CHAINS(TM) AND FLUOR-I-TIES(TM)
K900824 · EJF
Midwest Orthodontic Mfg.
Dental · 90d
Cleared May 21, 1990
THE TONGUE BRUSH
K901408 · LCN
Garry Laboratories, Inc.
Dental · 56d
Cleared May 15, 1990
BIOMER(R) F COMPOSITE LUTING CEMENT
K896340 · EMA
Dentsply Intl.
Dental · 193d
Cleared May 15, 1990
PUREBRUSH ULTRAVIOLET TOOTHBRUSH SANITIZER
K896481 · MCF
Purebrush Assoc.
Dental · 181d
Cleared May 15, 1990
INTERFACE BONDING SYSTEM
K896769 · EBF
Smile Horizons, Inc.
Dental · 165d
Cleared May 15, 1990
PALFIQUE LIGHT LINER
K896980 · EBI
Tokuyama America, Inc.
Dental · 153d
Cleared May 15, 1990
TOKUSO REBASE
K896981 · EBI
Tokuyama America, Inc.
Dental · 153d
Cleared May 15, 1990
PALFIQUE LIGHT BONDING AGENT
K897009 · KLE
Tokuyama America, Inc.
Dental · 153d
Cleared May 15, 1990
PALFIQUE LIGHT COMPOSITE RESIN
K897010 · EBF
Tokuyama America, Inc.
Dental · 153d
Cleared May 15, 1990
PALFIQUE LIGHT-S COMPOSITE RESIN
K897011 · EBF
Tokuyama America, Inc.
Dental · 153d
Cleared May 15, 1990
NOVUS BONDING AGENT
K900301 · EBI
The Hygenic Corp.
Dental · 113d
Cleared May 15, 1990
EPI DENT TOOTHBRUSH
K900766 · JEQ
Epi Mfg.
Dental · 88d
Cleared May 15, 1990
COMFORT ACRYLICS PLIABLE DENTURE LINERS & SPLINTS
K900799 · EBI
Comfort Acrylics Co.
Dental · 84d
Cleared May 15, 1990
SUNPAK AQUA FLOSS 2000 CORDLESS PERSONAL ORAL JET
K900991 · EFS
Tocad America, Inc.
Dental · 74d
Cleared May 15, 1990
TELEDYNE GETZ'S DISPOSABLE PROPHY ANGLE
K901239 · EFB
Teledyne Getz
Dental · 61d
Cleared May 15, 1990
CONCEPT INLAY/ONLAY
K901396 · EBF
Ivoclar North America, Inc.
Dental · 50d
Cleared May 15, 1990
LYNX-SM, SCLAER DENTAL HANDPIECE
K901488 · ELC
Mti Precision Products
Dental · 47d
Cleared May 07, 1990
FERMIT TEMPORARY MATERIAL
K896530 · EBF
Ivoclar North America, Inc.
Dental · 174d
Cleared May 07, 1990
CU-75 VISIBLE LIGHT-CURING UNIT
K900135 · EBZ
Kab Gloves Unltd.
Dental · 117d