INTEGRAL III DENTAL IMPLANT ABUTMENT

Implant, Endosseous, Root-form

CALCITEK, INC.

The following data is part of a premarket notification filed by Calcitek, Inc. with the FDA for Integral Iii Dental Implant Abutment.

Pre-market Notification Details

Device IDK932274
510k NumberK932274
Device Name:INTEGRAL III DENTAL IMPLANT ABUTMENT
ClassificationImplant, Endosseous, Root-form
Applicant CALCITEK, INC. 2320 FARADAY AVE. Carlsbad,  CA  92008 -7216
ContactDel Bene
CorrespondentDel Bene
CALCITEK, INC. 2320 FARADAY AVE. Carlsbad,  CA  92008 -7216
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-05-12
Decision Date1993-11-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889024011342 K932274 000

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