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510(k) K860817

ROOT CANAL ORGANIZER by Pacific Union Dental, Inc. — Product Code EIK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1986
Date Received
March 4, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Carver, Wax, Dental
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Pacific Union Dental, Inc.

  • K863500 — STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR (September 22, 1986)
  • K855111 — DISPOSABLE PLASTIC DENT IMPRESSION TRAYS 9 STYLES (March 6, 1986)
  • K855112 — DISPOSABLE 3IN CHECK BITE IMPRESSION TRAYS (March 6, 1986)
  • K855113 — FLOSS HOLDER (PLASTIC) (March 6, 1986)

Other clearances for product code EIK

  • K013993 — NEOCALEX (February 22, 2002)
  • K972642 — PERIO CONTROL II (January 26, 1998)
  • K902653 — PDS-2000 (September 13, 1990)
  • K851727 — 2020-1/2 TO 2220 VARIOUS DENTAL WAX & MODELLING CA (July 2, 1985)