FDA 510(k)

Dental Barriers and Sleeves (AB0006)

Номер K: K261956 · 2026-09-08

Дата решения2026-09-08

Код продуктаPEM

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

Dental Barriers and Sleeves (AB0006) is the device name listed in this FDA 510(k) record. The listed applicant is ANI Co., Ltd.. It received FDA 510(k) clearance on 2026-09-08 under 510(k) number K261956. The device is classified under product code PEM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Dental Barriers and Sleeves (AB0006)?

Dental Barriers and Sleeves (AB0006) is a medical device that received FDA 510(k) clearance on 2026-09-08. The listed applicant is ANI Co., Ltd.. The 510(k) number is K261956.

When did Dental Barriers and Sleeves (AB0006) receive FDA 510(k) clearance?

Dental Barriers and Sleeves (AB0006) received FDA 510(k) clearance on 2026-09-08, under 510(k) number K261956.

Who is the listed applicant for Dental Barriers and Sleeves (AB0006)?

The FDA 510(k) record lists ANI Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental Barriers and Sleeves (AB0006)?

The FDA product code for Dental Barriers and Sleeves (AB0006) is PEM.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Связанные устройства (Код: PEM)

K262073Hygienic Protective Bite Cover (2207-010-50)Dürr Dental SE K250735Dental Barrier and SleevesFomed Industries, Inc.K250606Dental Barrier and SleevesYueying Medical Instruments (Langfang) Co., Ltd.K242435Dental Barrier and SleevesWellmed Dental Medical Supply Co., Ltd.K233918Dental Barrier and SleevesYongqing Huaguan Dental Instruments Factory K220662Disposable Barrier SleevesPremium Plus (Dongguan) Limited

Официальный источник

Посмотреть в базе данных FDA →

Данные получены из открытого API FDA. Для получения наиболее актуальной и авторитетной информации всегда обращайтесь к официальным записям.