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510(k) K120283

DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT by Novocol, Inc. — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2012
Date Received
January 31, 2012
Clearance Type
Abbreviated
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 Novocol, Inc.

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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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