Cleared Traditional

Simply Iconic Implants

K201553 · Implant Direct Sybron Manufacturing, LLC · Dental
Jan 2021
Decision
226d
Days
Class 2
Risk

About This 510(k) Submission

K201553 is an FDA 510(k) clearance for the Simply Iconic Implants, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Implant Direct Sybron Manufacturing, LLC (Thousand Oaks, US). The FDA issued a Cleared decision on January 22, 2021, 226 days after receiving the submission on June 10, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K201553 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 2020
Decision Date January 22, 2021
Days to Decision 226 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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