Cleared Traditional

NobelParallel Conical Connection

K173418 · Nobel Biocare AB · Dental
Feb 2019
Decision
477d
Days
Class 2
Risk

About This 510(k) Submission

K173418 is an FDA 510(k) clearance for the NobelParallel Conical Connection, 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 February 21, 2019, 477 days after receiving the submission on November 1, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K173418 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 2017
Decision Date February 21, 2019
Days to Decision 477 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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