3M DENT II SYSTEM

Material, Tooth Shade, Resin

3M COMPANY

The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Dent Ii System.

Pre-market Notification Details

Device IDK981647
510k NumberK981647
Device Name:3M DENT II SYSTEM
ClassificationMaterial, Tooth Shade, Resin
Applicant 3M COMPANY 3M CENTER BLDG. 275-3SE-08 St. Paul,  MN  55144 -1000
ContactLeal Pickett
CorrespondentLeal Pickett
3M COMPANY 3M CENTER BLDG. 275-3SE-08 St. Paul,  MN  55144 -1000
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-05-11
Decision Date1998-08-09
Summary:summary

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