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510(k) K950121

FRANCE ORTHODONTIE by France Orthodontie — Product Code DZB

K950121 is an FDA 510(k) premarket notification submitted by France Orthodontie for the device "FRANCE ORTHODONTIE". The FDA issued a decision of Substantially Equivalent on March 8, 1995. The device falls under product code DZB (Headgear, Extraoral, Orthodontic), a Class II device regulated under 21 CFR 872.5500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 1995
Date Received
January 12, 1995
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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  • K000358 — MULTI ADJUSTABLE FACE MASK (June 9, 2000)
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FDA data resources