Dental Barrier and Sleeves
K-Number: K242435 · 2024-10-18
Decision Date2024-10-18
Product CodePEM
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Dental Barrier and Sleeves is a medical device manufactured by Wellmed Dental Medical Supply Co., Ltd.. It received FDA 510(k) clearance on 2024-10-18 under approval number K242435. 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 2024-10-18. It is manufactured by Wellmed Dental Medical Supply Co., Ltd.. The 510(k) number is K242435.
When was Dental Barrier and Sleeves approved by the FDA?
Dental Barrier and Sleeves received FDA 510(k) clearance on 2024-10-18, under approval number K242435.
What company makes Dental Barrier and Sleeves?
Dental Barrier and Sleeves is manufactured by Wellmed Dental Medical Supply Co., Ltd..
What is the FDA product code for Dental Barrier and Sleeves?
The FDA product code for Dental Barrier and Sleeves is PEM.
Related Clinical Trials
Other Devices by Wellmed Dental Medical Supply Co., Ltd.
Related Devices (Code: PEM)
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K163447Premium Plus Disposable Barrier SleevePremium Plus International Limited
K191448Barrier SleevesIvoclar Vivadent, AG
K190484BH Medical Dental Barrier Sleeves and Barrier FilmBh Medical Products Co., Ltd.
K190949ScanX Barrier EnvelopesAir Techniques, Inc.
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.