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."
49–72 of 130
Search insights Median review: 78d Cleared: 100% Top manufacturer: GC America, Inc. Lead specialty: Dental
Cleared Oct 30, 2008
GRADIA CORE
K082171 · EBF
GC America, Inc.
Dental · 90d
Cleared Oct 21, 2008
G-BOND PLUS
K082768 · KLE
GC America, Inc.
Dental · 29d
Cleared Jun 11, 2008
GC OPB-100
K080724 · DYH
GC America, Inc.
Dental · 89d
Cleared Jun 05, 2008
GRADIA FORTE
K080478 · EBF
GC America, Inc.
Dental · 104d
Cleared Apr 11, 2008
UNIFAST III
K073106 · EBG
GC America, Inc.
Dental · 161d
Cleared Mar 10, 2008
JNE IMPLANT SYSTEM
K072425 · DZE
GC America, Inc.
Dental · 194d
Cleared Feb 20, 2008
GC GAM-100
K073283 · EMA
GC America, Inc.
Dental · 91d
Cleared Feb 15, 2008
GC MODELS OPA-100 AND JC-50
K073588 · DYH
GC America, Inc.
Dental · 57d
Cleared Feb 14, 2008
GC AADVA ABUTMENT
K072100 · NHA
GC America, Inc.
Dental · 198d
Cleared Aug 09, 2007
GC-ZIRCONIA
K071674 · EIH
GC America, Inc.
Dental · 51d
Cleared May 15, 2007
GVC-100
K070840 · EMA
GC America, Inc.
Dental · 49d
Cleared Apr 12, 2007
GC MI PASTE PLUS
K070854 · EJR
GC America, Inc.
Dental · 15d
Cleared Mar 29, 2007
COE COMFORT
K070698 · EBI
GC America, Inc.
Dental · 16d
Cleared Mar 29, 2007
COE SOFT
K070697 · EBI
GC America, Inc.
Dental · 16d
Cleared Mar 12, 2007
GRADIA DIRECT X
K070190 · EBF
GC America, Inc.
Dental · 49d
Cleared Feb 26, 2007
GC FUJI IX GP EXTRA
K070319 · EMA
GC America, Inc.
Dental · 24d
Cleared Jul 14, 2006
GC XLC-100 CAPSULE
K061535 · EMA
GC America, Inc.
Dental · 42d
Cleared Oct 20, 2005
G-COAT
K052462 · EBD
GC America, Inc.
Dental · 42d
Cleared Aug 22, 2005
GC FUJI FIL LC
K051427 · EMA
GC America, Inc.
Dental · 82d
Cleared Jul 07, 2005
NATURE-CRYL HI PLUS
K051358 · EBI
GC America, Inc.
Dental · 44d
Cleared Mar 04, 2005
FUSION PUTTY TYPE
K043493 · ELW
GC America, Inc.
Dental · 77d
Cleared Feb 03, 2005
G-LIGHT
K050059 · EBZ
GC America, Inc.
Dental · 23d
Cleared Jan 27, 2005
FUSION FAST
K043471 · ELW
GC America, Inc.
Dental · 42d
Cleared Jan 25, 2005
GC TION GINGIVAL PROTECTOR
K043301 · EIE
GC America, Inc.
Dental · 56d