Cleared Traditional

PROCERA BRIDGE ZIRCONIA

K041283 · Nobel Biocare AB · Dental
May 2004
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K041283 is an FDA 510(k) clearance for the PROCERA BRIDGE ZIRCONIA, a Teeth, Porcelain (Class II — Special Controls, product code ELL), submitted by Nobel Biocare AB (Yorba Linda,, US). The FDA issued a Cleared decision on May 28, 2004, 15 days after receiving the submission on May 13, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.3920.

Submission Details

510(k) Number K041283 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 2004
Decision Date May 28, 2004
Days to Decision 15 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code ELL — Teeth, Porcelain
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3920

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