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510(k) K081143

BIOMERS TRANSLUCENT ORTHODONTIC WIRE by Biomers Product, LLC — Product Code DYW

K081143 is an FDA 510(k) premarket notification submitted by Biomers Product, LLC for the device "BIOMERS TRANSLUCENT ORTHODONTIC WIRE". The FDA issued a decision of Substantially Equivalent on May 2, 2008. The device falls under product code DYW (Bracket, Plastic, Orthodontic), a Class II device regulated under 21 CFR 872.5470.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2008
Date Received
April 22, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Bracket, Plastic, Orthodontic
Device Class
Class II
Regulation Number
872.5470
Review Panel
DE
Submission Type

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FDA data resources