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
8257–8280 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared May 31, 1995
DEGUSTAR GA-2
K951777 · EJT
Degussa Corp.
Dental · 44d
Cleared May 31, 1995
DEGUDENT U
K951778 · EJT
Degussa Corp.
Dental · 47d
Cleared May 25, 1995
LOWE KLEARWAY
K950763 · LRK
Dr. Alan A. Lowe, Inc.
Dental · 97d
Cleared May 25, 1995
COMPOLGLASS COMPOGLASS SCA
K951836 · EBF
Ivoclar North America, Inc.
Dental · 35d
Cleared May 25, 1995
ULTRA SPHERICAL AMALGAM ALLOY
K951865 · EJJ
Goldsmith & Revere, Inc.
Dental · 34d
Cleared May 24, 1995
DENTAL 911
K941066 · EMB
L.A.F. Industries, Inc.
Dental · 442d
Cleared May 24, 1995
ORTHODONTIC ELASTOMERIC LAGATURE MODULE
K943419 · ECI
Jon-Ko Products, Inc.
Dental · 313d
Cleared May 24, 1995
COLTOLUX 3, COLTOLUX 4
K945698 · EBZ
Coltene/Whaledent, Inc.
Dental · 188d
Cleared May 24, 1995
COLTOLUX LIGHT METER
K950106 · EBZ
Coltene/Whaledent, Inc.
Dental · 133d
Cleared May 23, 1995
ORTHODONTIC ELASTOMERIC TUBE/THREAD
K943417 · ECI
Jon-Ko Products, Inc.
Dental · 312d
Cleared May 23, 1995
ORTHODONTIC ELASTOMERIC SEPARATOR MODULE
K943418 · ECI
Jon-Ko Products, Inc.
Dental · 312d
Cleared May 23, 1995
ORTHODONTIC ELASTOMERIC CHAIN
K943420 · ECI
Jon-Ko Products, Inc.
Dental · 312d
Cleared May 23, 1995
ORTHODONITC ELASTOMERIC SLEEVING
K943421 · DZD
Jon-Ko Products, Inc.
Dental · 312d
Cleared May 23, 1995
CEREC 2
K950299 · ELW
Pelton & Crane Co.
Dental · 118d
Cleared May 23, 1995
SAFE-TIPS EZ
K951238 · EIA
Safe Wave Products, Inc.
Dental · 64d
Cleared May 23, 1995
FUJI IX
K951555 · EMA
GC America, Inc.
Dental · 49d
Cleared May 23, 1995
BAND SEATER
K951776 · ECR
Ormco Corp.
Dental · 40d
Cleared May 23, 1995
PRIME & BOND DIRECT COMPOSITE BONDING AGENT
K951864 · KLE
Dentsply Intl.
Dental · 32d
Cleared May 23, 1995
PERMAQUIK BONDING PRIMER
K951867 · KLE
Ultradent Products, Inc.
Dental · 32d
Cleared May 16, 1995
INTEGRAL VI BIOINTEGRATED DENTAL IMPLANT SYSTEM
K944327 · DZE
Calcitek, Inc.
Dental · 256d
Cleared May 15, 1995
AMERICAN DENTAL PRODUCTS (ADP), COMPOSITE RESTORATIVE MATERIAL
K951427 · EBF
American Dental Products, Inc.
Dental · 49d
Cleared May 12, 1995
HEMA-GLU
K951220 · KLE
Health-Dent Intl., Inc.
Dental · 53d
Cleared May 12, 1995
RELACS 7000
K951272 · ELC
Micro-Mega Societe Anonyme
Dental · 52d
Cleared May 12, 1995
AMERICAN DENTAL PRODUCTS (ADP), VISIBLE LIGHT CURE COMPOSITE DENTAL...
K951426 · EBF
American Dental Products, Inc.
Dental · 45d