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."
73–96 of 130
Search insights Median review: 78d Cleared: 100% Top manufacturer: GC America, Inc. Lead specialty: Dental
Cleared Nov 18, 2004
GRADIA DIRECT LOFLO
K042348 · EBF
GC America, Inc.
Dental · 80d
Cleared Oct 20, 2004
MI PASTE
K042200 · EJR
GC America, Inc.
Dental · 68d
Cleared Jun 29, 2004
G-BOND
K041471 · KLE
GC America, Inc.
Dental · 27d
Cleared Jun 25, 2004
GC FUSION
K041398 · ELW
GC America, Inc.
Dental · 30d
Cleared Apr 22, 2004
GC INITIAL MC, AL AND LF
K040567 · EIH
GC America, Inc.
Dental · 49d
Cleared Feb 02, 2004
GRADIA GUM
K033808 · EBF
GC America, Inc.
Dental · 56d
Cleared Oct 20, 2003
FIT CHECKER II
K032289 · ELW
GC America, Inc.
Dental · 88d
Cleared Jan 30, 2003
GRADIA DIRECT
K023814 · EBF
GC America, Inc.
Dental · 76d
Cleared Jan 22, 2003
EXAJET
K023751 · ELW
GC America, Inc.
Dental · 75d
Cleared Jan 16, 2003
TEMPORARY CEMENT-DC010002
K023727 · EMA
GC America, Inc.
Dental · 71d
Cleared Oct 18, 2002
ISO FUNCTIONAL
K022430 · ELW
GC America, Inc.
Dental · 85d
Cleared May 03, 2002
GC ELITE CEMENT 100
K021038 · EMA
GC America, Inc.
Dental · 32d
Cleared Apr 26, 2002
GC FUJI ORTHO BAND PASTE PAK
K020578 · DYH
GC America, Inc.
Dental · 64d
Cleared Mar 28, 2002
UNIFIL FLOW
K020342 · EBF
GC America, Inc.
Dental · 55d
Cleared Feb 28, 2002
GC FUJI LINING LC PASTE PAK
K020117 · EMA
GC America, Inc.
Dental · 45d
Cleared Feb 20, 2002
UNIFIL BOND
K013997 · KLE
GC America, Inc.
Dental · 78d
Cleared Oct 29, 2001
FUJI VII CAPSULE
K013198 · EMA
GC America, Inc.
Dental · 34d
Cleared Oct 16, 2001
REVOTEK LC
K012542 · EBC
GC America, Inc.
Dental · 70d
Cleared Aug 07, 2001
GC E-LIGHT
K012134 · EBZ
GC America, Inc.
Dental · 29d
Cleared Jan 16, 2001
PATTERN RESIN
K003817 · EBG
GC America, Inc.
Dental · 36d
Cleared Aug 16, 2000
LINKMAX
K001823 · EMA
GC America, Inc.
Dental · 61d
Cleared Jul 17, 2000
GC FUJICEM
K001730 · EMA
GC America, Inc.
Dental · 40d
Cleared Jul 05, 2000
GRADIA
K001518 · EBF
GC America, Inc.
Dental · 50d
Cleared Jan 27, 2000
AROMA FINE (NORMAL AND FAST SET)
K994077 · ELW
GC America, Inc.
Dental · 56d