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
8425–8448 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Dec 15, 1994
AQUAFRESH PLAQUE FIGHTING GUM
K944575 · EJR
Smithkline Beecham Consumer...
Dental · 87d
Cleared Dec 15, 1994
PULPDENT HARDSHELL
K945173 · EBF
Pulpdent Corp.
Dental · 55d
Cleared Dec 14, 1994
ORTHODONITC METAL REINFORCED PLASTIC BRACKET
K942826 · DYW
Gac Intl., Inc.
Dental · 183d
Cleared Dec 14, 1994
THE VIVACARE T.P.S. PROBE
K944848 · EIX
Rms Div.
Dental · 75d
Cleared Dec 14, 1994
PULPDENT HARD DENTAL POSTERIOR FILLING MATERIAL
K945018 · EBF
Pulpdent Corp.
Dental · 62d
Cleared Dec 14, 1994
PULPDENT RESIN CEMENT
K945056 · EBF
Pulpdent Corp.
Dental · 61d
Cleared Dec 14, 1994
PULPDENT HYBRID ANTERIOR COMPOSITE
K945057 · EBF
Pulpdent Corp.
Dental · 61d
Cleared Dec 14, 1994
PULPDENT MICROFILLED ANTERIOR COMPOSITE
K945058 · EBF
Pulpdent Corp.
Dental · 61d
Cleared Dec 14, 1994
PULPDENT DUAL CURE UNFILLED BONDING RESIN
K945112 · KLE
Pulpdent Corp.
Dental · 57d
Cleared Dec 14, 1994
PULPDENT CERVICAL RESTORATIVE
K945113 · EBF
Pulpdent Corp.
Dental · 57d
Cleared Dec 09, 1994
K6-1 DIAGNOSTIC SYSTEM VERSION 3.1
K944134 · KZM
Myo-Tronics, Inc.
Dental · 107d
Cleared Dec 09, 1994
POLYURETHANE SOLUTION 29% W/W
K944934 · LBH
Knowell Therapeutic Technologies,Inc.
Dental · 64d
Cleared Dec 08, 1994
PRODIGY
K944659 · EBF
Sybron Dental Specialties, Inc.
Dental · 78d
Cleared Dec 05, 1994
KIS-II IMPLANT SYSTEM/DRILLS
K944356 · DZE
Implant Center of the Palm Beaches
Dental · 111d
Cleared Dec 02, 1994
PROCERA ALL-CERAMIC PORCELAIN
K944702 · EIH
Nobelpharma USA, Inc.
Dental · 71d
Cleared Dec 02, 1994
3M TEMPCARE LIGHT CURE TEMPORARY SYSTEM
K944981 · EBG
3M Company
Dental · 56d
Cleared Nov 30, 1994
SURGICAL CUTTING BURS
K943540 · DZJ
Stryker Corp.
Dental · 131d
Cleared Nov 30, 1994
PULPDENT CALCIUM HYDROXIDE PREPARATIONS
K944945 · EJK
Pulpdent Corp.
Dental · 54d
Cleared Nov 30, 1994
INSTRUMENT,FILLING,PLASTIC,DENTAL
K945077 · EKJ
Worldwide Dental, Inc.
Dental · 44d
Cleared Nov 30, 1994
FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES
K945200 · KOO
Procter & Gamble Co.
Dental · 36d
Cleared Nov 29, 1994
METAL-LINED TRANSCEND CERAMIC BRACKET
K944286 · DYW
Unitek Corp.
Dental · 88d
Cleared Nov 29, 1994
LIFE
K944416 · EJK
Sybron Dental Specialties, Inc.
Dental · 78d
Cleared Nov 22, 1994
VIDENT IMPAC IMPLANT ACCESSORIES
K923395 · DZE
Vident
Dental · 865d
Cleared Nov 22, 1994
GLUMA 3 STEP BONDING SYSTEM/ GLUMA 3 PRIMER/DESENSITIZER
K933360 · KLE
Miles Inc., Dental Products
Dental · 501d