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FDA 510(k)

Dental Barrier and Sleeves

K-Number: K250606 · 2025-05-29

ApplicantYueying Medical Instruments (Langfang) Co., Ltd.
Decision Date2025-05-29
Product CodePEM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Dental Barrier and Sleeves is the device name listed in this FDA 510(k) record. The listed applicant is Yueying Medical Instruments (Langfang) Co., Ltd.. It received FDA 510(k) clearance on 2025-05-29 under 510(k) number K250606. 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 Barrier and Sleeves?

Dental Barrier and Sleeves is a medical device that received FDA 510(k) clearance on 2025-05-29. The listed applicant is Yueying Medical Instruments (Langfang) Co., Ltd.. The 510(k) number is K250606.

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

Dental Barrier and Sleeves received FDA 510(k) clearance on 2025-05-29, under 510(k) number K250606.

Who is the listed applicant for Dental Barrier and Sleeves?

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

What is the FDA product code for Dental Barrier and Sleeves?

The FDA product code for Dental Barrier and Sleeves 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.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 ABK201604Plasdent Disposable Barrier Sleeves and Barrier FilmPlasdent Corporation

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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