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510(k) K092501

LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL by Novocol, Inc. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 2009
Date Received
August 14, 2009
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type

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  • K120283 — DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT (July 31, 2012)
  • K120619 — ORTHODONTIC FLOWABLE BRACKET ADHESIVE (May 21, 2012)
  • K110484 — SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL (May 17, 2011)
  • K072150 — DIMER ACID DERIVED NANO-HYBRID COMPOSITE RESTORATIVE MATERIAL (September 13, 2007)
  • K040343 — TEMP F (August 3, 2004)

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