1Derful HS, 1Derful HT— 510(k) K210884

Substantially Equivalent

1derful, Inc.

FDA 510(k) clearance K210884 for 1Derful HS, 1Derful HT, Substantially Equivalent on 2021-07-27. Applicant: 1derful, Inc.. Device class: 2.

Clearance details

Applicant: 1derful, Inc.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2021-03-25
Decision date: 2021-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brookshire, TX, 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.