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510(k) K972985

SPLINT IT by Jeneric/Pentron, Inc. — Product Code ELS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1997
Date Received
August 11, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Splint, Endodontic Stabilizing
Device Class
Class II
Regulation Number
872.3890
Review Panel
DE
Submission Type

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Other clearances for product code ELS

  • K961704 — MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEM (July 26, 1996)
  • K922673 — FLEXIBLE CERAMIC ROPES AND TAPES FOR BONDING (February 25, 1994)
  • K834363 — ENDIX RADICULAR BIOCERAMIC PIN (February 27, 1984)
  • K811209 — JACOB WIRZ TRANSFIXATION PIN (June 16, 1981)
  • K801525 — ZEST ENDODONTIC STABILIZER (July 21, 1980)