FOUNDATION HYBRID COMPOSITE— 510(k) K904135

Name: FDA 510(k) clearance K904135
Creator: U.S. Food and Drug Administration
Published: 1991-05-15

Substantially Equivalent

Nulite Systems Research

FDA 510(k) clearance K904135 for FOUNDATION HYBRID COMPOSITE, Substantially Equivalent on 1991-05-15. Applicant: Nulite Systems Research. Device class: 2.

Clearance details

Applicant: Nulite Systems Research
Product code: Code EBD
Device class: Class 2
Regulation: 21 CFR 872.3310
Advisory panel: Dental
Date received: 1990-09-06
Decision date: 1991-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Australia, AU

Download summary PDF View on FDA.gov ↗

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