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FDA 510(k)

UltraPrint-Dental Denture UV

K-Number: K253324 · 2025-11-20

ApplicantGuangzhou Heygears IMC., Inc.
Decision Date2025-11-20
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

UltraPrint-Dental Denture UV is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Heygears IMC., Inc.. It received FDA 510(k) clearance on 2025-11-20 under 510(k) number K253324. 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 UltraPrint-Dental Denture UV?

UltraPrint-Dental Denture UV is a medical device that received FDA 510(k) clearance on 2025-11-20. The listed applicant is Guangzhou Heygears IMC., Inc.. The 510(k) number is K253324.

When did UltraPrint-Dental Denture UV receive FDA 510(k) clearance?

UltraPrint-Dental Denture UV received FDA 510(k) clearance on 2025-11-20, under 510(k) number K253324.

Who is the listed applicant for UltraPrint-Dental Denture UV?

The FDA 510(k) record lists Guangzhou Heygears IMC., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UltraPrint-Dental Denture UV?

The FDA product code for UltraPrint-Dental Denture UV is EBI.

Other records listing Guangzhou Heygears IMC., Inc. as applicant

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 UVK253798UltraPrint-Dental Hard Splint UVK213643UltraPrint-Dental Temp C&B UV

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

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

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