SEPTOSIL SILICONE FOR PRECISION IMPRESSION— 510(k) K851388

Name: FDA 510(k) clearance K851388
Creator: U.S. Food and Drug Administration
Published: 1985-05-29

Substantially Equivalent

Specialites Septodont

FDA 510(k) clearance K851388 for SEPTOSIL SILICONE FOR PRECISION IMPRESSION, Substantially Equivalent on 1985-05-29. Applicant: Specialites Septodont. Device class: 2.

Clearance details

Applicant: Specialites Septodont
Product code: Product code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 1985-04-09
Decision date: 1985-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.