Cleared Special

NobelZygoma 0?

K183069 · Nobel Biocare AB · Dental
Dec 2018
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K183069 is an FDA 510(k) clearance for the NobelZygoma 0?, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Nobel Biocare AB (Goteborg, SE). The FDA issued a Cleared decision on December 4, 2018, 29 days after receiving the submission on November 5, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K183069 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 2018
Decision Date December 04, 2018
Days to Decision 29 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZE — Implant, Endosseous, Root-form
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3640

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