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510(k) K925240

FACEBOW by Forestadent Bernhard Forster GmbH — Product Code DZB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 1993
Date Received
October 16, 1992
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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  • K924971 — FORESTADENT BRACKETS (May 27, 1993)

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  • K052553 — NITOM LOCKING FACEBOW (December 22, 2005)
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  • K000358 — MULTI ADJUSTABLE FACE MASK (June 9, 2000)
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