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510(k) K873671

COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEM by Coltene, Inc. — Product Code EKS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1987
Date Received
September 11, 1987
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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  • K840297 — COLTENE ORALLOY MAGICAPS (March 16, 1984)
  • K811666 — COLTENE COLTEX/COLTOFLAX (July 15, 1981)

Other clearances for product code EKS

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  • K971319 — NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES (May 22, 1997)
  • K970649 — HERO 642 (May 16, 1997)
  • K962031 — QUANTEC SERIES 2000 ENDODONTIC FILES (June 4, 1996)
  • 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)
  • K902018 — DENTAURUM CERAMIC DEBONDING UNIT (April 3, 1991)