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510(k) K240688

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

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

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  • K223365 — RODIN Palette Naturalizing Kit (March 27, 2023)
  • K211420 — Stasis Gel (March 14, 2022)
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  • K200462 — EtchPro Etching Gel (September 2, 2020)

Other clearances for product code EBI

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  • K252430 — Freeprint® denture flex (October 30, 2025)
  • K252035 — DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink p (September 17, 2025)
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  • K242897 — Partial Flex (June 3, 2025)
  • K250489 — FP3D (May 20, 2025)
  • K250617 — Apex Flex (April 29, 2025)
  • K243356 — Asiga DentaBASE (April 11, 2025)