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510(k) K940410

NEW GEAR RELEASABLE HEADGEAR by Ortho Kinetics Corp. — Product Code DZB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1994
Date Received
January 27, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Headgear, Extraoral, Orthodontic
Device Class
Class II
Regulation Number
872.5500
Review Panel
DE
Submission Type

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  • K980151 — RELEASABLE FORCE MODULE (April 6, 1998)
  • K980195 — FACEBOW (March 11, 1998)

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