TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG

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 Temporary Gingival Cuff And Impression Post And Implant Analog.

Pre-market Notification Details

Device IDK001786
510k NumberK001786
Device Name:TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG
ClassificationImplant, Endosseous, Root-form
Applicant SULZER CALCITEK, INC. 1900 ASTON AVE. Carlsbad,  CA  92008 -7308
ContactFoster Boop
CorrespondentFoster Boop
SULZER CALCITEK, INC. 1900 ASTON AVE. Carlsbad,  CA  92008 -7308
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-06-13
Decision Date2000-06-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889024012981 K001786 000
00889024012646 K001786 000
00889024012639 K001786 000
00889024012622 K001786 000
00889024012615 K001786 000
00889024012608 K001786 000
00889024012592 K001786 000
00889024012585 K001786 000
00889024012578 K001786 000
00889024012653 K001786 000
00889024012660 K001786 000
00889024012677 K001786 000
00889024012974 K001786 000
00889024012950 K001786 000
00889024012943 K001786 000
00889024012929 K001786 000
00889024012912 K001786 000
00889024012707 K001786 000
00889024012691 K001786 000
00889024012684 K001786 000
00889024012561 K001786 000

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