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510(k) K980053

GLENROE CHAIN by Glenroe Technologies — Product Code ECI

K980053 is an FDA 510(k) premarket notification submitted by Glenroe Technologies for the device "GLENROE CHAIN". The FDA issued a decision of Substantially Equivalent on February 24, 1998. The device falls under product code ECI (Band, Elastic, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Glenroe Technologies has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1998
Date Received
January 6, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Band, Elastic, Orthodontic
Device Class
Class I
Regulation Number
872.5410
Review Panel
DE
Submission Type

Other clearances by Glenroe Technologies

  • K945535 — GLENROE ORTHO-SIL (January 27, 1995)
  • K924351 — GLENROE ELASTIBITE STIMULATOR (January 6, 1994)
  • 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 ECI

  • K980864 — POWER COINS GLOW IN THE DARK LIGATURES (April 20, 1998)
  • K973495 — GLENROE GLOW IN DARK ELASTOMERIC LIGATURES (December 1, 1997)
  • K943419 — ORTHODONTIC ELASTOMERIC LAGATURE MODULE (May 24, 1995)
  • K943420 — ORTHODONTIC ELASTOMERIC CHAIN (May 23, 1995)
  • K943417 — ORTHODONTIC ELASTOMERIC TUBE/THREAD (May 23, 1995)
  • K943418 — ORTHODONTIC ELASTOMERIC SEPARATOR MODULE (May 23, 1995)
  • K940165 — ALASTIK (March 7, 1994)
  • K932298 — PRO'S NEO-LASTICS (February 14, 1994)
  • K935144 — DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS (February 4, 1994)
  • K932319 — ORTHODONTIC ELASTOMER (September 20, 1993)

FDA data resources