510(k) K240688

RODIN Titan 3D Resin by Belport Company, Inc., Gingi-Pak — Product Code EBI

K240688 is an FDA 510(k) premarket notification submitted by Belport Company, Inc., Gingi-Pak for the device "RODIN Titan 3D Resin". The FDA issued a decision of Substantially Equivalent on June 20, 2024. The device falls under product code EBI (Resin, Denture, Relining, Repairing, Rebasing), a Class II device regulated under 21 CFR 872.3760. Belport Company, Inc., Gingi-Pak has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2024
Date Received
March 13, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resin, Denture, Relining, Repairing, Rebasing
Device Class
Class II
Regulation Number
872.3760
Review Panel
DE
Submission Type