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510(k) K111668

CAVIOS CAVITY LINER by Neodental Chemical Products Co., Ltd. — Product Code EJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2011
Date Received
June 14, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Liner, Cavity, Calcium Hydroxide
Device Class
Class II
Regulation Number
872.3250
Review Panel
DE
Submission Type

Other clearances by Neodental Chemical Products Co., Ltd.

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  • K971642 — DENTALIS KEZ ENDODONITC SEALER (July 24, 1997)
  • K955703 — NEO DENTAL ENDODONTIC IRRIGATION SYRINGE (May 20, 1996)

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