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510(k) K130601

BIOROOT RCS by Novocol, Inc. — Product Code KIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2013
Date Received
March 7, 2013
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resin, Root Canal Filling
Device Class
Class II
Regulation Number
872.3820
Review Panel
DE
Submission Type

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  • K120619 — ORTHODONTIC FLOWABLE BRACKET ADHESIVE (May 21, 2012)
  • K110484 — SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL (May 17, 2011)
  • K092501 — LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL (November 12, 2009)
  • K072150 — DIMER ACID DERIVED NANO-HYBRID COMPOSITE RESTORATIVE MATERIAL (September 13, 2007)
  • K040343 — TEMP F (August 3, 2004)

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