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510(k) K120404

MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH by Merz Dental GmbH — Product Code ELM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2012
Date Received
February 9, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Denture, Plastic, Teeth
Device Class
Class II
Regulation Number
872.3590
Review Panel
DE
Submission Type

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