ELLIPTIC MATRIX

Abutment, Implant, Dental, Endosseous

INSTITUT STRAUMANN AG

The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Elliptic Matrix.

Pre-market Notification Details

Device IDK040539
510k NumberK040539
Device Name:ELLIPTIC MATRIX
ClassificationAbutment, Implant, Dental, Endosseous
Applicant INSTITUT STRAUMANN AG RESERVOIR PLACE 1601 TRAPELO ROAD Waltham,  MA  02451
ContactJohn King
CorrespondentJohn King
INSTITUT STRAUMANN AG RESERVOIR PLACE 1601 TRAPELO ROAD Waltham,  MA  02451
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-03-02
Decision Date2004-03-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630031724700 K040539 000
07630031724694 K040539 000

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