REMESENSE— 510(k) K082594

Substantially Equivalent

Remedent NV

FDA 510(k) clearance K082594 for REMESENSE, Substantially Equivalent on 2009-03-19. Applicant: Remedent NV. Device class: 2.

Clearance details

Applicant: Remedent NV
Product code: Code LBH
Device class: Class 2
Regulation: 21 CFR 872.3260
Advisory panel: Dental
Date received: 2008-09-08
Decision date: 2009-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Claremont, NH, 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.