FDA.report

510(k) K253324

Device
UltraPrint-Dental Denture UV
Applicant
Guangzhou Heygears IMC., Inc.
510(k) number
K253324
Product code
EBI
Decision
Substantially Equivalent (SESE)
Decision date
2025-11-20
Date received
2025-09-30
Regulation
872.3760
Classification name
Resin, Denture, Relining, Repairing, Rebasing
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Mingyang Qu
Address
Block B2, 501,601, Enterprise Accelerator, Kaifa District Guangzhou CN 510700 510700

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
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06971437942321UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INC2026-03-05
06971437942338UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INC2026-03-05
06971437942352UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INC2026-03-05
06971437942376UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INC2026-03-05
06971437942383UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INC2026-03-05
06971437942390UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INC2026-03-05
06971437942406UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INC2026-03-05
06971437942413UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INC2026-03-05
06971437942208UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INC2026-03-04
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06971437942307UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INC2026-03-04
06971437942215UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INC2026-03-04
06971437942222UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INC2026-03-04
06971437942239UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INC2026-03-04
06971437942246UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INC2026-03-04
06971437942253UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INC2026-03-04
06971437942260UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INC2026-03-04
06971437942277UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INC2026-03-04
06971437942284UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INC2026-03-04
06971437942291UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INC2026-03-04

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