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510(k) K011748

FIRST FILL R.C.S. by Jeneric/Pentron, Inc. — Product Code KIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2001
Date Received
June 6, 2001
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 Jeneric/Pentron, Inc.

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  • K013543 — BOND-1 C & B (February 22, 2002)
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  • K012231 — AVANTE MICRO CRYSTAL SYSTEM (August 23, 2001)
  • K010957 — QUELL DESENSITIZER (June 25, 2001)
  • K011330 — JP CAST 50 (June 22, 2001)
  • K011331 — JP CAST 40 (June 22, 2001)
  • K011362 — GOLD CORE 73 LS (May 29, 2001)
  • K010044 — COSMIC (February 9, 2001)
  • K003683 — AVANTE CURELIGHT (January 11, 2001)

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