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510(k) K111855

HY-BOND RESIGLASS by Shofu Dental Corp. — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2011
Date Received
June 29, 2011
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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  • K080834 — VINTAGE ART (June 11, 2008)
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  • K071742 — BEAUTIFIL II (August 15, 2007)

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