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510(k) K231100

Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw by Proimtech Saglik Urunleri Anonim Sirketi — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2024
Date Received
April 18, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

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