Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

130 results for "GC America, Inc."
97–120 of 130
Search insights Median review: 78d Cleared: 100% Top manufacturer: GC America, Inc. Lead specialty: Dental
Cleared Jan 11, 2000
FUJI II LC CAPSULE
K993973 · EBF
GC America, Inc.
Dental · 49d
Cleared Jul 09, 1999
ACRON MC MODIFICATION
K991774 · EBI
GC America, Inc.
Dental · 45d
Cleared May 28, 1999
GC RELINE SOFT/EXTRA SOFT
K990736 · EBI
GC America, Inc.
Dental · 84d
Cleared Feb 25, 1999
GC UNIFAST TRAD
K984365 · EBI
GC America, Inc.
Dental · 80d
Cleared Feb 04, 1999
MIRACLE MIX POWDER/LIQUID
K984505 · EMA
GC America, Inc.
Dental · 48d
Cleared Oct 19, 1998
GC RELINE
K982695 · EBI
GC America, Inc.
Dental · 77d
Cleared Jun 25, 1998
GC FUJI ORTHO LC
K981461 · DYH
GC America, Inc.
Dental · 63d
Cleared Jun 16, 1998
GC FUJI BOND LC
K981514 · KLE
GC America, Inc.
Dental · 49d
Cleared Jun 01, 1998
MIRACLE MIX CAPSULE
K981370 · EMA
GC America, Inc.
Dental · 47d
Cleared Apr 13, 1998
FUJI I
K980695 · EMA
GC America, Inc.
Dental · 49d
Cleared Apr 03, 1998
FUJI II
K980682 · EMA
GC America, Inc.
Dental · 39d
Cleared Oct 21, 1997
HYDROFLEX
K973343 · ELW
GC America, Inc.
Dental · 46d
Cleared Aug 26, 1997
METALPRIMER II
K972594 · KLE
GC America, Inc.
Dental · 46d
Cleared Apr 08, 1997
HYDROFLEX
K970656 · ELW
GC America, Inc.
Dental · 46d
Cleared Oct 29, 1996
GC BASELINE
K963144 · EBI
GC America, Inc.
Dental · 77d
Cleared Jul 08, 1996
FUJI IX GP
K961448 · EMA
GC America, Inc.
Dental · 83d
Cleared May 24, 1996
FUJI II LC (IMPROVED)
K961584 · EMA
GC America, Inc.
Dental · 30d
Cleared May 24, 1996
GC FUJI ORTHO
K961417 · DYH
GC America, Inc.
Dental · 42d
Cleared Mar 11, 1996
EXAFLEX IMPRESSION MATERIAL (MODIFICATION)
K955932 · ELW
GC America, Inc.
Dental · 89d
Cleared Sep 27, 1995
FUJI BOND LC
K953166 · KLE
GC America, Inc.
Dental · 82d
Cleared May 23, 1995
FUJI IX
K951555 · EMA
GC America, Inc.
Dental · 49d
Cleared Mar 08, 1995
FUJI ORTHO LC
K950556 · DYH
GC America, Inc.
Dental · 29d
Cleared Feb 07, 1995
THERMORESIN LC II
K942993 · EBF
GC America, Inc.
Dental · 232d
Cleared Jan 20, 1995
FUJI DUET
K946100 · EMA
GC America, Inc.
Dental · 37d