SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENT

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 Dental Implant System-temporary Abutment.

Pre-market Notification Details

Device IDK982305
510k NumberK982305
Device Name:SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENT
ClassificationImplant, Endosseous, Root-form
Applicant SULZER CALCITEK, INC. 2320 FARADAY AVE. Carlsbad,  CA  92008
ContactFoster Boop
CorrespondentFoster Boop
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 Received1998-07-01
Decision Date1998-09-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889024013254 K982305 000
00889024013247 K982305 000
00889024013230 K982305 000
00889024013223 K982305 000
00889024013216 K982305 000
00889024013209 K982305 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.