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510(k) K220640

Bifix Hybrid Abutment Cement by Voco GmbH — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2022
Date Received
March 4, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Dental
Device Class
Class II
Regulation Number
872.3275
Review Panel
DE
Submission Type

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