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510(k) K973667

VITAPEX PRE-LOADED DENTAL SYRINGE by Neodental Chemical Products Co., Ltd. — Product Code KIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1997
Date Received
September 25, 1997
Clearance Type
Traditional
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

Other clearances by Neodental Chemical Products Co., Ltd.

  • K111666 — EVADYNE TEMPORARY CROWN AND BRIDGE RESIN (September 7, 2011)
  • K111668 — CAVIOS CAVITY LINER (August 19, 2011)
  • K971642 — DENTALIS KEZ ENDODONITC SEALER (July 24, 1997)
  • K955703 — NEO DENTAL ENDODONTIC IRRIGATION SYRINGE (May 20, 1996)

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