GOLD/PALLADIUM BASED DENTAL ALLOY— 510(k) K885302

Substantially Equivalent

Jelenko Co.

FDA 510(k) clearance K885302 for GOLD/PALLADIUM BASED DENTAL ALLOY, Substantially Equivalent on 1989-02-13. Applicant: Jelenko Co.. Device class: 2.

Clearance details

Applicant
Jelenko Co.
Product code
Code EJT
Device class
Class 2
Regulation
21 CFR 872.3060
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Armonk, NY, US
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