REMESENSE FOR SENSITIVE TEETH— 510(k) K122708

Substantially Equivalent

Sylphar N.V.

FDA 510(k) clearance K122708 for REMESENSE FOR SENSITIVE TEETH, Substantially Equivalent on 2013-01-14. Applicant: Sylphar N.V.. Device class: 2.

Clearance details

Applicant: Sylphar N.V.
Product code: Code LBH
Device class: Class 2
Regulation: 21 CFR 872.3260
Advisory panel: Dental
Date received: 2012-09-04
Decision date: 2013-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rome, IT

Download summary PDF View on FDA.gov ↗

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