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510(k) K902018

DENTAURUM CERAMIC DEBONDING UNIT by Dentauraum, Inc. — Product Code EKS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1991
Date Received
May 3, 1990
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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  • K942665 — ORTHOCENT: LIQUID AND POWDER (July 22, 1994)

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  • K953604 — SHAPING HEDSTROM N.T. (September 28, 1995)
  • K935542 — NICKEL-TITANIUM K-TYPE FILE (January 3, 1994)
  • K932529 — LIGHTSPEED DENTAL HAND INSTRUMENT (November 4, 1993)
  • K933582 — PROFILE SERIES 29 FILES (October 20, 1993)
  • K905461 — PROCEDURE KIT/ROUTINE DENTAL PROCEDURES (March 5, 1991)