Cleared Traditional

NobelProcera HT ML Full Contour Zirconia Crown

K153534 · Nobel Biocare AB · Dental
Jun 2016
Decision
180d
Days
Class 2
Risk

About This 510(k) Submission

K153534 is an FDA 510(k) clearance for the NobelProcera HT ML Full Contour Zirconia Crown, a Teeth, Porcelain (Class II — Special Controls, product code ELL), submitted by Nobel Biocare AB (Goteborg, SE). The FDA issued a Cleared decision on June 6, 2016, 180 days after receiving the submission on December 9, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.3920.

Submission Details

510(k) Number K153534 FDA.gov
FDA Decision Cleared SESE
Date Received December 09, 2015
Decision Date June 06, 2016
Days to Decision 180 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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