A DENTAL AMALGAM ALLOY (UNNAMED— 510(k) K820389

Substantially Equivalent

Dentsply Intl.

FDA 510(k) clearance K820389 for A DENTAL AMALGAM ALLOY (UNNAMED, Substantially Equivalent on 1982-03-11. Applicant: Dentsply Intl.. Device class: 2.

Clearance details

Applicant: Dentsply Intl.
Product code: Code EJJ
Device class: Class 2
Regulation: 21 CFR 872.3070
Advisory panel: Dental
Date received: 1982-02-10
Decision date: 1982-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K820389

K-number listed on FDA's recall record

Z-1006-2024 — Article No. NA6050411, Valiant PhD No. 1 EconoClass II·Ongoing·Ivoclar Vivadent, Inc.·20231221

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K820389.

Data sourced from openFDA. This site is unofficial and independent of the FDA.