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510(k) K134021

ESTEMP IMPLANT, ESTEMP CLEAR by Spident Co., Ltd. — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2014
Date Received
December 30, 2013
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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Other clearances for product code EMA

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