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510(k) K260783

Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One by Kulzer, LLC — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2026
Date Received
March 10, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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