Cleared Traditional

TREFOIL System

K172352 · Nobel Biocare AB · Dental
Oct 2017
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K172352 is an FDA 510(k) clearance for the TREFOIL System, 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 October 20, 2017, 78 days after receiving the submission on August 3, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K172352 FDA.gov
FDA Decision Cleared SESE
Date Received August 03, 2017
Decision Date October 20, 2017
Days to Decision 78 days
Submission Type Traditional
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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