TURBO TEMP 3

Crown And Bridge, Temporary, Resin

DANVILLE MATERIALS, INC.

The following data is part of a premarket notification filed by Danville Materials, Inc. with the FDA for Turbo Temp 3.

Pre-market Notification Details

Device IDK102753
510k NumberK102753
Device Name:TURBO TEMP 3
ClassificationCrown And Bridge, Temporary, Resin
Applicant DANVILLE MATERIALS, INC. 3420 FOSTORIA WAY, SUITE A-200 San Ramon,  CA  94583
ContactLindsay Tilton
CorrespondentLindsay Tilton
DANVILLE MATERIALS, INC. 3420 FOSTORIA WAY, SUITE A-200 San Ramon,  CA  94583
Product CodeEBG  
CFR Regulation Number872.3770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-23
Decision Date2011-02-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817169020165 K102753 000
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00854212006615 K102753 000
20843471128583 K102753 000
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00854212006646 K102753 000
00854212006653 K102753 000
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00816577020095 K102753 000
00816577020088 K102753 000
00816577020071 K102753 000
00854212006660 K102753 000
20843471128170 K102753 000

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