PREMIER PROMAX BITE GUARD— 510(k) K941856

Name: FDA 510(k) clearance K941856
Creator: U.S. Food and Drug Administration
Published: 1995-04-05

Substantially Equivalent

Premier Dental Products Co.

FDA 510(k) clearance K941856 for PREMIER PROMAX BITE GUARD, Substantially Equivalent on 1995-04-05. Applicant: Premier Dental Products Co.. Device class: 2.

Clearance details

Applicant: Premier Dental Products Co.
Product code: Code JXL
Device class: Class 2
Regulation: 21 CFR 882.5070
Advisory panel: Neurology
Date received: 1994-04-15
Decision date: 1995-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Philadelphia, PA, 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.