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."
25–48 of 130
Search insights Median review: 78d Cleared: 100% Top manufacturer: GC America, Inc. Lead specialty: Dental
Cleared Mar 03, 2016
GC Reline II
K153253 · EBI
GC America, Inc.
Dental · 114d
Cleared Oct 09, 2015
G-Fix
K151541 · EBF
GC America, Inc.
Dental · 123d
Cleared May 07, 2015
GC KommonBase
K143667 · DYH
Gc Orthodontics America, Inc.
Dental · 135d
Cleared Apr 20, 2015
G-Premio BOND
K143140 · KLE
GC America, Inc.
Dental · 168d
Cleared Sep 05, 2014
MSN-006
K141562 · EBG
GC America, Inc.
Dental · 85d
Cleared Apr 09, 2014
HTFX-222
K133182 · EBF
GC America, Inc.
Dental · 174d
Cleared Mar 14, 2014
CERASMART
K133824 · EBF
GC America, Inc.
Dental · 87d
Cleared Mar 06, 2014
OPTIGLAZE COLOR
K133836 · EBD
GC America, Inc.
Dental · 78d
Cleared Jul 23, 2013
MFP-051
K123631 · EBF
GC America, Inc.
Dental · 242d
Cleared Jan 30, 2013
GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SV
K113816 · NHA
GC America, Inc.
Dental · 400d
Cleared Jun 27, 2012
GAM-200
K120243 · EMA
GC America, Inc.
Dental · 152d
Cleared May 10, 2012
GC BLUE SILICONE
K120521 · ELW
GC America, Inc.
Dental · 79d
Cleared Jun 30, 2011
GC AADVA BO AC ABUTMENTS
K103234 · NHA
GC America, Inc.
Dental · 240d
Cleared Jun 17, 2011
FIT CHECKER ADVANCED
K110871 · ELW
GC America, Inc.
Dental · 80d
Cleared Jan 27, 2011
GC ORAL MOISTURIZING GEL
K101346 · LFD
GC America, Inc.
Dental · 259d
Cleared Dec 22, 2010
MI VARNISH
K102808 · LBH
GC America, Inc.
Dental · 85d
Cleared Dec 06, 2010
GC AADVA IMPLANT SYSTEM
K093749 · DZE
GC America, Inc.
Dental · 364d
Cleared Sep 17, 2010
GC FUJI TEMP
K101420 · EMA
GC America, Inc.
Dental · 120d
Cleared Sep 29, 2009
AADVA ZR COLORING LIQUID
K092020 · EIH
GC America, Inc.
Dental · 85d
Cleared Jul 22, 2009
GCUC-505
K091388 · EBF
GC America, Inc.
Dental · 72d
Cleared Jun 17, 2009
EQUIA
K091106 · EMA
GC America, Inc.
Dental · 62d
Cleared Jun 10, 2009
MI FLOW (GCUC-450)
K090747 · EBF
GC America, Inc.
Dental · 82d
Cleared Nov 26, 2008
GC AADVA ZR DISK
K082740 · EIH
GC America, Inc.
Dental · 69d
Cleared Nov 14, 2008
GDLS-200
K082434 · EBF
GC America, Inc.
Dental · 81d