DISTAFLEX— 510(k) K823280

Substantially Equivalent

Duradent Corp.

FDA 510(k) clearance K823280 for DISTAFLEX, Substantially Equivalent on 1982-11-22. Applicant: Duradent Corp.. Device class: 1.

Clearance details

Applicant
Duradent Corp.
Product code
Code EGG
Device class
Class 1
Regulation
21 CFR 872.3165
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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