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510(k) K924351

GLENROE ELASTIBITE STIMULATOR by Glenroe Technologies — Product Code KMY

K924351 is an FDA 510(k) premarket notification submitted by Glenroe Technologies for the device "GLENROE ELASTIBITE STIMULATOR". The FDA issued a decision of Substantially Equivalent on January 6, 1994. The device falls under product code KMY (Positioner, Tooth, Preformed), a Class I device regulated under 21 CFR 872.5525. Glenroe Technologies has at least 8 other 510(k) clearances on record.

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

Other clearances by Glenroe Technologies

  • K980053 — GLENROE CHAIN (February 24, 1998)
  • K945535 — GLENROE ORTHO-SIL (January 27, 1995)
  • K932920 — GLENROE PLASTIC BRACKET (August 24, 1993)
  • K931462 — GLENROE CHAIN (July 22, 1993)
  • K924140 — TUFF TIES (April 27, 1993)
  • K924139 — GLENROE ORTHO SEPS (April 8, 1993)
  • K924211 — EJECTOR (March 31, 1993)
  • K924993 — GLENROE BAND SEATING CONTOURING INSTRUMENT (November 25, 1992)

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)

FDA data resources