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510(k) K110484

SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL by Novocol, Inc. — Product Code EBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2011
Date Received
February 18, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Crown And Bridge, Temporary, Resin
Device Class
Class II
Regulation Number
872.3770
Review Panel
DE
Submission Type

Other clearances by Novocol, Inc.

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  • K120283 — DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT (July 31, 2012)
  • K120619 — ORTHODONTIC FLOWABLE BRACKET ADHESIVE (May 21, 2012)
  • 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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