SPLINE ENGAGING SHOULDERED ABUTMENT SYSTEM

Implant, Endosseous, Root-form

SULZER CALCITEK, INC.

The following data is part of a premarket notification filed by Sulzer Calcitek, Inc. with the FDA for Spline Engaging Shouldered Abutment System.

Pre-market Notification Details

Device IDK970752
510k NumberK970752
Device Name:SPLINE ENGAGING SHOULDERED ABUTMENT SYSTEM
ClassificationImplant, Endosseous, Root-form
Applicant SULZER CALCITEK, INC. 2320 FARADAY AVE. Carlsbad,  CA  92008
ContactJoseph S Shan
CorrespondentJoseph S Shan
SULZER CALCITEK, INC. 2320 FARADAY AVE. Carlsbad,  CA  92008
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-03-03
Decision Date1997-06-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889024011663 K970752 000

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