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510(k) K214118

Riva Cem Automix by Sdi Limited — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2022
Date Received
December 30, 2021
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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