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510(k) K980864

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

K980864 is an FDA 510(k) premarket notification submitted by Ortho Kinetics Corp. for the device "POWER COINS GLOW IN THE DARK LIGATURES". The FDA issued a decision of Substantially Equivalent on April 20, 1998. The device falls under product code ECI (Band, Elastic, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Ortho Kinetics Corp. has at least 6 other 510(k) clearances on record.

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

Other clearances by Ortho Kinetics Corp.

  • K982088 — AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM (September 4, 1998)
  • K980436 — CLASS III REVERSE PULL FACEMASK (April 27, 1998)
  • K980245 — NITOM LOCKING FACEBOW (April 21, 1998)
  • K980151 — RELEASABLE FORCE MODULE (April 6, 1998)
  • K980195 — FACEBOW (March 11, 1998)
  • K940410 — NEW GEAR RELEASABLE HEADGEAR (March 10, 1994)

Other clearances for product code ECI

  • K980053 — GLENROE CHAIN (February 24, 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)
  • 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