3M Protemp Cement Temporary Dental Cement

Cement, Dental

3M Company

The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Protemp Cement Temporary Dental Cement.

Pre-market Notification Details

Device IDK170330
510k NumberK170330
Device Name:3M Protemp Cement Temporary Dental Cement
ClassificationCement, Dental
Applicant 3M Company 2510 Conway Avenue St. Paul,  MN  55144 -1000
ContactGretchen Keenan
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2017-02-02
Decision Date2017-02-06
Summary:summary

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