510(k) K260805

Dual Core by Vericom Co., Ltd. — Product Code EBF

K260805 is an FDA 510(k) premarket notification submitted by Vericom Co., Ltd. for the device "Dual Core". The FDA issued a decision of Substantially Equivalent on May 11, 2026. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Vericom Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2026
Date Received
March 12, 2026
Clearance Type
Traditional
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