Dental Barrier and Sleeves
K-Number: K250606 · 2025-05-29
Decision Date2025-05-29
Product CodePEM
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Dental Barrier and Sleeves is a medical device manufactured by Yueying Medical Instruments (Langfang) Co., Ltd.. It received FDA 510(k) clearance on 2025-05-29 under approval 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. It is manufactured by Yueying Medical Instruments (Langfang) Co., Ltd.. The 510(k) number is K250606.
When was Dental Barrier and Sleeves approved by the FDA?
Dental Barrier and Sleeves received FDA 510(k) clearance on 2025-05-29, under approval number K250606.
What company makes Dental Barrier and Sleeves?
Dental Barrier and Sleeves is manufactured by Yueying Medical Instruments (Langfang) Co., Ltd..
What is the FDA product code for Dental Barrier and Sleeves?
The FDA product code for Dental Barrier and Sleeves is PEM.
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K191448Barrier SleevesIvoclar Vivadent, AG
K190484BH Medical Dental Barrier Sleeves and Barrier FilmBh Medical Products Co., Ltd.
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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.