LUXATEMP/LUXATEMP SOLAR/INSTATEMP

Crown And Bridge, Temporary, Resin

DMG USA, INC.

The following data is part of a premarket notification filed by Dmg Usa, Inc. with the FDA for Luxatemp/luxatemp Solar/instatemp.

Pre-market Notification Details

Device IDK013674
510k NumberK013674
Device Name:LUXATEMP/LUXATEMP SOLAR/INSTATEMP
ClassificationCrown And Bridge, Temporary, Resin
Applicant DMG USA, INC. 5 WHITCOMB AVE. Ayer,  MA  01432
ContactPamela Papineau
CorrespondentPamela Papineau
DMG USA, INC. 5 WHITCOMB AVE. Ayer,  MA  01432
Product CodeEBG  
CFR Regulation Number872.3770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-11-07
Decision Date2002-01-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850048528925 K013674 000
D0026663500 K013674 000
D0026663600 K013674 000
D0026663700 K013674 000
00841549100383 K013674 000
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EDMG1103608 K013674 000
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EDMG1104018 K013674 000
D0026663450 K013674 000
D0026663400 K013674 000
00850048528932 K013674 000
D0026662001 K013674 000
D0026662100 K013674 000
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D0026662300 K013674 000
D0026662400 K013674 000
D0026662450 K013674 000
D0026663200 K013674 000
D0026663300 K013674 000
EDMG1104028 K013674 000
EDMG1104038 K013674 000
D813CR10390 K013674 000
D813CR10400 K013674 000
D813CR10410 K013674 000
D813CR10420 K013674 000
D813CR10430 K013674 000
D813SPD13000 K013674 000
D813SPD13010 K013674 000
D813SPD13020 K013674 000
D813SPD13030 K013674 000
EDMG1107230 K013674 000
EDMG1107221 K013674 000
EDMG1104048 K013674 000
EDMG1104061 K013674 000
EDMG1105858 K013674 000
EDMG1105868 K013674 000
EDMG1105878 K013674 000
EDMG1105888 K013674 000
EDMG1105898 K013674 000
EDMG1107108 K013674 000
EDMG1107191 K013674 000
D813SPD13200 K013674 000

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