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510(k) K191122

3M RelyX Pediatric Resin Modified Glass Ionomer Cement by 3M Espe Dental Products — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2019
Date Received
April 29, 2019
Clearance Type
Traditional
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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