CMFlexTM— 510(k) K213260

Substantially Equivalent

Dimension Inx Corp.

FDA 510(k) clearance K213260 for CMFlexTM, Substantially Equivalent on 2022-12-30. Applicant: Dimension Inx Corp.. Device class: 2.

Clearance details

Applicant: Dimension Inx Corp.
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2021-09-30
Decision date: 2022-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.