Cleared Traditional

Implant Direct Dental Implant Systems Portfolio - MR Conditional

K222211 · Implant Direct Sybron Manufacturing, LLC · Dental

Feb 2023

Decision

192d

Days

Class 2

Risk

About This 510(k) Submission

K222211 is an FDA 510(k) clearance for the Implant Direct Dental Implant Systems Portfolio - MR Conditional, 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 February 2, 2023, 192 days after receiving the submission on July 25, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number	K222211 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 25, 2022
Decision Date	February 02, 2023
Days to Decision	192 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement