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510(k) K843344

ACTIVE VERTICAL CORRECTOR ACTIVE BITE by Active Vertical Correctors, Inc. — Product Code ECO

K843344 is an FDA 510(k) premarket notification submitted by Active Vertical Correctors, Inc. for the device "ACTIVE VERTICAL CORRECTOR ACTIVE BITE". The FDA issued a decision of Substantially Equivalent on December 3, 1984. The device falls under product code ECO (Spring, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Active Vertical Correctors, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1984
Date Received
August 27, 1984
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 by Active Vertical Correctors, Inc.

  • K844234 — ACTIVE VERTICAL CORRECTOR APPLIANCE (January 4, 1985)

Other clearances for product code ECO

  • K943068 — MAGNEFORCE (August 17, 1994)
  • K933542 — MESIAL LOOP BAR (August 5, 1994)
  • K942492 — ADJUSTABLE BITE CORRECTOR (July 13, 1994)
  • K844234 — ACTIVE VERTICAL CORRECTOR APPLIANCE (January 4, 1985)
  • K843550 — ORTHOMAG MAGNETIC FORCE SYSTEM (December 21, 1984)
  • K770558 — ISODYNE (April 5, 1977)

FDA data resources