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510(k) K240888

Calibra Abutment Resin Cement by Dentsply Sirona — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2024
Date Received
April 1, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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Other clearances for product code EMA

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