SIMPLER HA THREADED, ST 5002-8, SIT 5002-8, ST 5011-ST5014, ST 5021-24

Implant, Endosseous, Root-form

SIMPLER IMPLANT, INC.

The following data is part of a premarket notification filed by Simpler Implant, Inc. with the FDA for Simpler Ha Threaded, St 5002-8, Sit 5002-8, St 5011-st5014, St 5021-24.

Pre-market Notification Details

Device IDK060376
510k NumberK060376
Device Name:SIMPLER HA THREADED, ST 5002-8, SIT 5002-8, ST 5011-ST5014, ST 5021-24
ClassificationImplant, Endosseous, Root-form
Applicant SIMPLER IMPLANT, INC. 404-1023 WOLFE AVENUE Vancouver, Bc,  CA V6h 1v6
ContactKaren Bergman
CorrespondentKaren Bergman
SIMPLER IMPLANT, INC. 404-1023 WOLFE AVENUE Vancouver, Bc,  CA V6h 1v6
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-02-14
Decision Date2006-04-25

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