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510(k) K821625

ENDODONTIC PAPERPOINTS by Roeko — Product Code EKN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1982
Date Received
June 2, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Point, Paper, Endodontic
Device Class
Class I
Regulation Number
872.3830
Review Panel
DE
Submission Type

Other clearances for product code EKN

  • K843017 — ABSORBENT ENDODONTIC POINT (January 9, 1985)
  • K812886 — ENDODONTIC PAPER POINTS (November 16, 1981)
  • K800827 — PREMIER ABSORBENT POINTS (April 29, 1980)
  • K781605 — R&R ABSORBENT POINTS (October 10, 1978)
  • K761203 — ABSORBENT POINTS (December 13, 1976)
  • K760983 — ENDODONTIC INSTRUMENTS (November 15, 1976)