Cleared Traditional

NobelProcera HT ML FCZ Bridge

K162043 · Nobel Biocare AB · Dental
Nov 2016
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K162043 is an FDA 510(k) clearance for the NobelProcera HT ML FCZ Bridge, a Teeth, Porcelain (Class II — Special Controls, product code ELL), submitted by Nobel Biocare AB (Goteborg, SE). The FDA issued a Cleared decision on November 22, 2016, 120 days after receiving the submission on July 25, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.3920.

Submission Details

510(k) Number K162043 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2016
Decision Date November 22, 2016
Days to Decision 120 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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