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510(k) K993224

T-GEAR, MODEL TG/400-700 by Dontech Products B.V. — Product Code DZB

K993224 is an FDA 510(k) premarket notification submitted by Dontech Products B.V. for the device "T-GEAR, MODEL TG/400-700". The FDA issued a decision of Substantially Equivalent on February 11, 2000. 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
February 11, 2000
Date Received
September 27, 1999
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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FDA data resources