HYDROXYLAPATITE COATED ENDOSSEOUS DENT

Implant, Endosseous, Root-form

CALCITEK, INC.

The following data is part of a premarket notification filed by Calcitek, Inc. with the FDA for Hydroxylapatite Coated Endosseous Dent.

Pre-market Notification Details

Device IDK840750
510k NumberK840750
Device Name:HYDROXYLAPATITE COATED ENDOSSEOUS DENT
ClassificationImplant, Endosseous, Root-form
Applicant CALCITEK, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-02-23
Decision Date1984-04-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889024011458 K840750 000
00889024011441 K840750 000

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