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510(k) K955703

NEO DENTAL ENDODONTIC IRRIGATION SYRINGE by Neodental Chemical Products Co., Ltd. — Product Code KIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1996
Date Received
December 14, 1995
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.

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  • K973667 — VITAPEX PRE-LOADED DENTAL SYRINGE (November 6, 1997)
  • K971642 — DENTALIS KEZ ENDODONITC SEALER (July 24, 1997)

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