SOLARO 33— 510(k) K970045

Substantially Equivalent

Metalor Dental USA Corp.

FDA 510(k) clearance K970045 for SOLARO 33, Substantially Equivalent on 1997-03-05. Applicant: Metalor Dental USA Corp.. Device class: 2.

Clearance details

Applicant: Metalor Dental USA Corp.
Product code: Code EJS
Device class: Class 2
Regulation: 21 CFR 872.3060
Advisory panel: Dental
Date received: 1997-01-06
Decision date: 1997-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleborough, MA, 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.