Cleared Traditional

GBR System

K233419 · Proimtech Saglik Urunleri Anonim Sirketi · Dental
Jan 2025
Decision
451d
Days
Class 2
Risk

About This 510(k) Submission

K233419 is an FDA 510(k) clearance for the GBR System, a Screw, Fixation, Intraosseous (Class II — Special Controls, product code DZL), submitted by Proimtech Saglik Urunleri Anonim Sirketi (Istanbul, TR). The FDA issued a Cleared decision on January 3, 2025, 451 days after receiving the submission on October 10, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.4880.

Submission Details

510(k) Number K233419 FDA.gov
FDA Decision Cleared SESE
Date Received October 10, 2023
Decision Date January 03, 2025
Days to Decision 451 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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