GC FUJI ORTHO LC

Adhesive, Bracket And Tooth Conditioner, Resin

GC AMERICA, INC.

The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Gc Fuji Ortho Lc.

Pre-market Notification Details

Device IDK981461
510k NumberK981461
Device Name:GC FUJI ORTHO LC
ClassificationAdhesive, Bracket And Tooth Conditioner, Resin
Applicant GC AMERICA, INC. 3737 WEST 127TH ST. Alsip,  IL  60803
ContactTerry L Joritz
CorrespondentTerry L Joritz
GC AMERICA, INC. 3737 WEST 127TH ST. Alsip,  IL  60803
Product CodeDYH  
CFR Regulation Number872.3750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-04-23
Decision Date1998-06-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D6584230081 K981461 000
00386040009808 K981461 000
20386040009796 K981461 000
20386040009697 K981461 000
20386040009680 K981461 000
00386040008658 K981461 000
14548161072601 K981461 000
24548161283240 K981461 000
24548161283035 K981461 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.