PALCERAM 53— 510(k) K001479

Substantially Equivalent

Aurex SA (Pty) , Ltd.

FDA 510(k) clearance K001479 for PALCERAM 53, Substantially Equivalent on 2000-06-21. Applicant: Aurex SA (Pty) , Ltd.. Device class: 2.

Clearance details

Applicant: Aurex SA (Pty) , Ltd.
Product code: Code EJT
Device class: Class 2
Regulation: 21 CFR 872.3060
Advisory panel: Dental
Date received: 2000-05-11
Decision date: 2000-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edenvale, Gauteng, ZA

Download summary PDF View on FDA.gov ↗

Recent devices under product code EJT

More clearances from Aurex SA (Pty) , Ltd.

K001481 — PALCERAM 492000-06-23
K001482 — AURENORM 75 KF2000-06-23
K001480 — AURECAST 40 B2000-06-21
K001477 — AURELUX Y 84 PREMIUM2000-06-20
K001478 — AURECAST SUPER INLAY2000-06-20

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