Plasdent Disposable Barrier Sleeves and Barrier Film
K-Number: K201604 · 2020-12-23
ApplicantPlasdent Corporation
Decision Date2020-12-23
Product CodePEM
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Plasdent Disposable Barrier Sleeves and Barrier Film is a medical device manufactured by Plasdent Corporation. It received FDA 510(k) clearance on 2020-12-23 under approval number K201604. 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 Plasdent Disposable Barrier Sleeves and Barrier Film?
Plasdent Disposable Barrier Sleeves and Barrier Film is a medical device that received FDA 510(k) clearance on 2020-12-23. It is manufactured by Plasdent Corporation. The 510(k) number is K201604.
When was Plasdent Disposable Barrier Sleeves and Barrier Film approved by the FDA?
Plasdent Disposable Barrier Sleeves and Barrier Film received FDA 510(k) clearance on 2020-12-23, under approval number K201604.
What company makes Plasdent Disposable Barrier Sleeves and Barrier Film?
Plasdent Disposable Barrier Sleeves and Barrier Film is manufactured by Plasdent Corporation.
What is the FDA product code for Plasdent Disposable Barrier Sleeves and Barrier Film?
The FDA product code for Plasdent Disposable Barrier Sleeves and Barrier Film is 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.