Cleared Traditional

SAVE GBR

K222367 · Dentis Co., Ltd. · Dental
Mar 2023
Decision
230d
Days
Class 2
Risk

About This 510(k) Submission

K222367 is an FDA 510(k) clearance for the SAVE GBR, a Screw, Fixation, Intraosseous (Class II — Special Controls, product code DZL), submitted by Dentis Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on March 23, 2023, 230 days after receiving the submission on August 5, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.4880.

Submission Details

510(k) Number K222367 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 2022
Decision Date March 23, 2023
Days to Decision 230 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZL — Screw, Fixation, Intraosseous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4880

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