POLY SILOXANE IMPRESSION MATERIAL

Material, Impression

MILLENNIUM DENTAL INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Millennium Dental International, Inc. with the FDA for Poly Siloxane Impression Material.

Pre-market Notification Details

Device IDK053018
510k NumberK053018
Device Name:POLY SILOXANE IMPRESSION MATERIAL
ClassificationMaterial, Impression
Applicant MILLENNIUM DENTAL INTERNATIONAL, INC. 1980 HYDE PARK London, Ontario,  CA N6h 5l9
ContactJeanette Smith
CorrespondentJeanette Smith
MILLENNIUM DENTAL INTERNATIONAL, INC. 1980 HYDE PARK London, Ontario,  CA N6h 5l9
Product CodeELW  
CFR Regulation Number872.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-10-26
Decision Date2005-11-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D811TEMPMATRIXMX2610 K053018 000
07540172017435 K053018 000
07540172017428 K053018 000
07540172017411 K053018 000
07540172017404 K053018 000
07540172017398 K053018 000
07540172017381 K053018 000
07540172017374 K053018 000
07540172017367 K053018 000
07540172017350 K053018 000
07540172017343 K053018 000
07540172017442 K053018 000
D811ACUFLOWMX2610 K053018 000
D811SILICONESR2300 K053018 000
D811RIGIDTRAYRB4010 K053018 000
D811PUTTYVPSKITPK9010 K053018 000
D811MEDIUMBODYMB3010 K053018 000
D811LIGHTBODYREGLBR5010 K053018 000
D811LIGHTBODYPLUSLB6010 K053018 000
D811HEAVYBODYHB7010 K053018 000
D811HARDBITEBR8010 K053018 000
D811HARDBESTBITEBR8050 K053018 000
D811BALANCEBITEBR8120 K053018 000
07540172017336 K053018 000

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