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510(k) K970649

HERO 642 by Micro-Mega — Product Code EKS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1997
Date Received
February 20, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
File, Pulp Canal, Endodontic
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

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  • K902018 — DENTAURUM CERAMIC DEBONDING UNIT (April 3, 1991)
  • K905461 — PROCEDURE KIT/ROUTINE DENTAL PROCEDURES (March 5, 1991)