3M SUSTEL DENTAL 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 Sustel Dental System.

Pre-market Notification Details

Device IDK970500
510k NumberK970500
Device Name:3M SUSTEL DENTAL SYSTEM
ClassificationMaterial, Tooth Shade, Resin
Applicant 3M COMPANY 3M CENTER BLDG. 275-3SE-08 St. Paul,  MN  55144 -1000
ContactRebecca L Hannack
CorrespondentRebecca L Hannack
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 Received1997-02-10
Decision Date1997-04-30

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