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510(k) K922673

FLEXIBLE CERAMIC ROPES AND TAPES FOR BONDING by Glasspan, Inc. — Product Code ELS

K922673 is an FDA 510(k) premarket notification submitted by Glasspan, Inc. for the device "FLEXIBLE CERAMIC ROPES AND TAPES FOR BONDING". The FDA issued a decision of Substantially Equivalent on February 25, 1994. The device falls under product code ELS (Splint, Endodontic Stabilizing), a Class II device regulated under 21 CFR 872.3890.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1994
Date Received
June 4, 1992
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 for product code ELS

  • K972985 — SPLINT IT (September 24, 1997)
  • K961704 — MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEM (July 26, 1996)
  • K834363 — ENDIX RADICULAR BIOCERAMIC PIN (February 27, 1984)
  • K811209 — JACOB WIRZ TRANSFIXATION PIN (June 16, 1981)
  • K801525 — ZEST ENDODONTIC STABILIZER (July 21, 1980)

FDA data resources