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510(k) K834363

ENDIX RADICULAR BIOCERAMIC PIN by C.B.S. Biotechnics, Inc. — Product Code ELS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1984
Date Received
October 27, 1983
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

Other clearances by C.B.S. Biotechnics, Inc.

  • K834364 — CRYSTALLINE BONE SCREW ENDO-OSSEOUS (March 6, 1984)
  • K834361 — JSB JET SYRINGE (March 5, 1984)
  • K834366 — SURGICAL INSTRUMENTS & ACCESSORIES (February 27, 1984)

Other clearances for product code ELS

  • K972985 — SPLINT IT (September 24, 1997)
  • K961704 — MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEM (July 26, 1996)
  • K922673 — FLEXIBLE CERAMIC ROPES AND TAPES FOR BONDING (February 25, 1994)
  • K811209 — JACOB WIRZ TRANSFIXATION PIN (June 16, 1981)
  • K801525 — ZEST ENDODONTIC STABILIZER (July 21, 1980)