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510(k) K980864

POWER COINS GLOW IN THE DARK LIGATURES by Ortho Kinetics Corp. — Product Code ECI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1998
Date Received
March 5, 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

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  • K940410 — NEW GEAR RELEASABLE HEADGEAR (March 10, 1994)

Other clearances for product code ECI

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  • 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)