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510(k) K080517

RESICEM by Shofu Dental Corp. — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2008
Date Received
February 25, 2008
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

Other clearances by Shofu Dental Corp.

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  • K110252 — BEAUTIBOND MULTI PR PLUS (May 13, 2011)
  • K101621 — LITE ART (August 23, 2010)
  • K101603 — BEAUTIFIL FLOW PLUS (August 23, 2010)
  • K093559 — VINTAGE MP (March 3, 2010)
  • K082744 — BEAUTIBOND (December 11, 2008)
  • K080834 — VINTAGE ART (June 11, 2008)
  • K080068 — BEAUTIFIL OPAQUER (February 28, 2008)
  • K071742 — BEAUTIFIL II (August 15, 2007)

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