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510(k) K082207

ORTHOCAD IQ by Cadent, Inc. — Product Code DYW

K082207 is an FDA 510(k) premarket notification submitted by Cadent, Inc. for the device "ORTHOCAD IQ". The FDA issued a decision of Substantially Equivalent on October 23, 2009. 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
October 23, 2009
Date Received
August 5, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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