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510(k) K973495

GLENROE GLOW IN DARK ELASTOMERIC LIGATURES by Glenroe — Product Code ECI

K973495 is an FDA 510(k) premarket notification submitted by Glenroe for the device "GLENROE GLOW IN DARK ELASTOMERIC LIGATURES". The FDA issued a decision of Substantially Equivalent on December 1, 1997. The device falls under product code ECI (Band, Elastic, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Glenroe has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 1997
Date Received
September 16, 1997
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

  • K923124 — GLENROE GOLDEN ORTHODONTIC BRACKET (August 27, 1992)

Other clearances for product code ECI

  • K980864 — POWER COINS GLOW IN THE DARK LIGATURES (April 20, 1998)
  • K980053 — GLENROE CHAIN (February 24, 1998)
  • K943419 — ORTHODONTIC ELASTOMERIC LAGATURE MODULE (May 24, 1995)
  • K943420 — ORTHODONTIC ELASTOMERIC CHAIN (May 23, 1995)
  • K943418 — ORTHODONTIC ELASTOMERIC SEPARATOR MODULE (May 23, 1995)
  • K943417 — ORTHODONTIC ELASTOMERIC TUBE/THREAD (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