TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS

Implant, Endosseous, Root-form

STRAUMANN USA

The following data is part of a premarket notification filed by Straumann Usa with the FDA for Tl 04.1mm Rn,s, Slactive Tizr 6, 8, 10, 12, 14, 16mm Dental Implants.

Pre-market Notification Details

Device IDK122855
510k NumberK122855
Device Name:TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS
ClassificationImplant, Endosseous, Root-form
Applicant STRAUMANN USA 60 MINUTEMAN ROAD Andover,  MA  01810
ContactElaine Alan
CorrespondentElaine Alan
STRAUMANN USA 60 MINUTEMAN ROAD Andover,  MA  01810
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-09-18
Decision Date2012-12-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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