GC XLC-100 CAPSULE

Cement, Dental

GC AMERICA, INC.

The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Gc Xlc-100 Capsule.

Pre-market Notification Details

Device IDK061535
510k NumberK061535
Device Name:GC XLC-100 CAPSULE
ClassificationCement, Dental
Applicant GC AMERICA, INC. 3737 WEST 127TH ST. Alsip,  IL  60803
ContactTerry L Joritz-lyons
CorrespondentTerry L Joritz-lyons
GC AMERICA, INC. 3737 WEST 127TH ST. Alsip,  IL  60803
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-06-02
Decision Date2006-07-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00386040009419 K061535 000
04548161330230 K061535 000
04548161330223 K061535 000
04548161293504 K061535 000
04548161293498 K061535 000
04548161291135 K061535 000
04548161282409 K061535 000
04548161282331 K061535 000
04548161282256 K061535 000

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