Dental Barriers and Sleeves (AB0006)— 510(k) K261956

Name: FDA 510(k) clearance K261956
Creator: U.S. Food and Drug Administration
Published: 2026-09-08

Substantially Equivalent

ANI Co., Ltd.

FDA 510(k) clearance K261956 for Dental Barriers and Sleeves (AB0006), Substantially Equivalent on 2026-09-08. Applicant: ANI Co., Ltd.. Device class: 2.

Clearance details

Applicant: ANI Co., Ltd.
Product code: Code PEM
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 2026-06-11
Decision date: 2026-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwon-Si, Gyeonggi-Do, KR

Download summary PDF View on FDA.gov ↗

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