HELIOSIT-ORTHODONTIC— 510(k) K823409

Substantially Equivalent

Vivadent (Usa), Inc.

FDA 510(k) clearance K823409 for HELIOSIT-ORTHODONTIC, Substantially Equivalent on 1983-01-21. Applicant: Vivadent (Usa), Inc.. Device class: 2.

Clearance details

Applicant: Vivadent (Usa), Inc.
Product code: Code DYH
Device class: Class 2
Regulation: 21 CFR 872.3750
Advisory panel: Dental
Date received: 1982-11-15
Decision date: 1983-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amherst, NY, US

Download summary PDF View on FDA.gov ↗

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