FDA.reportPublic FDA data

510(k) K242277

Device
Crown HT
Applicant
Sprintray, Inc.
510(k) number
K242277
Product code
EBF
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-01
Date received
2024-08-01
Regulation
872.3690
Classification name
Material, Tooth Shade, Resin
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Sara Moghtadernejad
Address
2710 Media Center Dr., Suite #100a Los Angeles CA US 90065 90065

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EBF#

510(k), Device, Applicant table
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K260805Dual CoreVericom Co., Ltd.2026-05-11
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K261357Grandio disc multicolorVoco GmbH2026-04-27
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K260661Midas RestoreSprintray, Inc.2026-04-15
K253036Light-curing Coloring Materials (ALCM)Aidite (Qinhuangdao) Technology Co., Ltd.2026-04-06
K260783Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow OneKulzer, LLC2026-03-11