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FDA 510(k)

Dental Barriers and Sleeves (AB0006)

K-Number: K261956 · 2026-09-08

ApplicantANI Co., Ltd.
Decision Date2026-09-08
Product CodePEM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: PEM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 FactoryK220662Disposable Barrier SleevesPremium Plus (Dongguan) LimitedK211026Minitube Dentasleeve Protective Barrier SleevesMinitube AB

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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