STRYKER PRECISION DENTAL IMPLANT SYSTEM

Implant, Endosseous, Root-form

STRYKER INSTRUMENTS

The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Stryker Precision Dental Implant System.

Pre-market Notification Details

Device IDK921805
510k NumberK921805
Device Name:STRYKER PRECISION DENTAL IMPLANT SYSTEM
ClassificationImplant, Endosseous, Root-form
Applicant STRYKER INSTRUMENTS 420 ALCOTT ST. Kalamazoo,  MI  49001
ContactChad A Coberly
CorrespondentChad A Coberly
STRYKER INSTRUMENTS 420 ALCOTT ST. Kalamazoo,  MI  49001
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-04-15
Decision Date1994-03-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00813110022851 K921805 000
00813110022844 K921805 000
00813110022547 K921805 000
00813110022530 K921805 000
00813110022516 K921805 000
00813110022509 K921805 000
00813110029126 K921805 000

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