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510(k) K201795

Transcend by Ultradent Product, Inc. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2020
Date Received
June 30, 2020
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type

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