Cleared Traditional

BIOUNIVERSAL PDF

K011022 · Ivoclar North America, Inc. · Dental
May 2001
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K011022 is an FDA 510(k) clearance for the BIOUNIVERSAL PDF, a Alloy, Gold-based Noble Metal (Class II — Special Controls, product code EJT), submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on May 2, 2001, 28 days after receiving the submission on April 4, 2001. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K011022 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 2001
Decision Date May 02, 2001
Days to Decision 28 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJT — Alloy, Gold-based Noble Metal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3060

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