OPTODENT/OPTOGNATH— 510(k) K936058

Substantially Equivalent

Spectrum Healthcare Group

FDA 510(k) clearance K936058 for OPTODENT/OPTOGNATH, Substantially Equivalent on 1994-05-16. Applicant: Spectrum Healthcare Group. Device class: 2.

Clearance details

Applicant: Spectrum Healthcare Group
Product code: Code ELM
Device class: Class 2
Regulation: 21 CFR 872.3590
Advisory panel: Dental
Date received: 1993-12-20
Decision date: 1994-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairburn, GA, 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.