FDA 510(k)

Dental Barriers and Sleeves (AB0006)

Número K: K261956 · 2026-09-08

Data da decisão2026-09-08

Código do produtoPEM

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Fonte oficial

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