Neo GBR System— 510(k) K160991

Name: FDA 510(k) clearance K160991
Creator: U.S. Food and Drug Administration
Published: 2017-01-10

Substantially Equivalent

Neobiotech Co., Ltd.

FDA 510(k) clearance K160991 for Neo GBR System, Substantially Equivalent on 2017-01-10. Applicant: Neobiotech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Neobiotech Co., Ltd.
Product code: Code DZL
Device class: Class 2
Regulation: 21 CFR 872.4880
Advisory panel: Dental
Date received: 2016-04-08
Decision date: 2017-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DZL

product code DZL

Injury: 168
Total: 168

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.