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510(k) K130076

PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS by Merz Dental GmbH — Product Code EBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2013
Date Received
January 14, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resin, Denture, Relining, Repairing, Rebasing
Device Class
Class II
Regulation Number
872.3760
Review Panel
DE
Submission Type

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