DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI.— 510(k) K883842

Name: FDA 510(k) clearance K883842
Creator: U.S. Food and Drug Administration
Published: 1989-03-17

Substantially Equivalent

Dentsply Intl.

FDA 510(k) clearance K883842 for DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI., Substantially Equivalent on 1989-03-17. Applicant: Dentsply Intl.. Device class: 2.

Clearance details

Applicant: Dentsply Intl.
Product code: Product code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 1988-09-12
Decision date: 1989-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

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