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510(k) K942492

ADJUSTABLE BITE CORRECTOR by Orthoplus, Inc. — Product Code ECO

K942492 is an FDA 510(k) premarket notification submitted by Orthoplus, Inc. for the device "ADJUSTABLE BITE CORRECTOR". The FDA issued a decision of Substantially Equivalent on July 13, 1994. The device falls under product code ECO (Spring, Orthodontic), a Class I device regulated under 21 CFR 872.5410.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1994
Date Received
May 25, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances for product code ECO

  • K943068 — MAGNEFORCE (August 17, 1994)
  • K933542 — MESIAL LOOP BAR (August 5, 1994)
  • K844234 — ACTIVE VERTICAL CORRECTOR APPLIANCE (January 4, 1985)
  • K843550 — ORTHOMAG MAGNETIC FORCE SYSTEM (December 21, 1984)
  • K843344 — ACTIVE VERTICAL CORRECTOR ACTIVE BITE (December 3, 1984)
  • K770558 — ISODYNE (April 5, 1977)

FDA data resources