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FDA 510(k)

RODIN Titan 3D Resin

K-Number: K240688 · 2024-06-20

ApplicantBelport Company, Inc., Gingi-Pak
Decision Date2024-06-20
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RODIN Titan 3D Resin is the device name listed in this FDA 510(k) record. The listed applicant is Belport Company, Inc., Gingi-Pak. It received FDA 510(k) clearance on 2024-06-20 under 510(k) number K240688. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RODIN Titan 3D Resin?

RODIN Titan 3D Resin is a medical device that received FDA 510(k) clearance on 2024-06-20. The listed applicant is Belport Company, Inc., Gingi-Pak. The 510(k) number is K240688.

When did RODIN Titan 3D Resin receive FDA 510(k) clearance?

RODIN Titan 3D Resin received FDA 510(k) clearance on 2024-06-20, under 510(k) number K240688.

Who is the listed applicant for RODIN Titan 3D Resin?

The FDA 510(k) record lists Belport Company, Inc., Gingi-Pak as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RODIN Titan 3D Resin?

The FDA product code for RODIN Titan 3D Resin is EBI.

Other records listing Belport Company, Inc., Gingi-Pak as applicant

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Related Devices (Code: EBI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, Inc.K260376Denture BaseShandong Huge Dental Material Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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