FDA.report

510(k) K250953

Device
EQUIA LC ONE
Applicant
GC America, Inc.
510(k) number
K250953
Product code
EMA
Decision
Substantially Equivalent (SESE)
Decision date
2025-09-19
Date received
2025-03-28
Regulation
872.3275
Classification name
Cement, Dental
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Futoshi Fusejima
Address
3737 W. 127th St. Alsip IL US 60803 60803

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code EMA

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K242366OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-AbutmentOverfibers S.R.L.2025-01-10
K240714Insure® Universal; Insure® Universal AutomixCosmedent, Inc.2024-07-24
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K233161BeautiLink SAShofu Dental Corporation2023-09-28