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510(k) K924351

GLENROE ELASTIBITE STIMULATOR by Glenroe Technologies — Product Code KMY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 1994
Date Received
August 28, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Positioner, Tooth, Preformed
Device Class
Class I
Regulation Number
872.5525
Review Panel
DE
Submission Type

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  • K924211 — EJECTOR (March 31, 1993)
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Other clearances for product code KMY

  • K931615 — NITE-GUIDE (April 14, 1995)
  • K942667 — DENT-O-CRYL ORTHODONTIC ACRYLIC (February 13, 1995)
  • K925064 — RELAX-O-GUARD (September 13, 1993)
  • K924975 — THE ORTHOTRAINER (July 8, 1993)
  • K924974 — THE TMJ APPLIANCE (June 23, 1993)
  • K904128 — PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER (November 9, 1990)
  • K891328 — PREFORMED TEMPLATE FOR TOOTH POSITIONER (March 31, 1989)
  • K833455 — REMOLDABLE CRANIOMANDIBULAR APPLIANCE (January 10, 1984)
  • K831793 — AQUALIZER MOUTHPIECE (August 12, 1983)
  • K821458 — DYNAMIC FUNTIONAL POSITIONER (June 9, 1982)