Barrier Sleeves
K-Number: K191448 · 2019-10-08
ApplicantIvoclar Vivadent, AG
Decision Date2019-10-08
Product CodePEM
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Barrier Sleeves is a medical device manufactured by Ivoclar Vivadent, AG. It received FDA 510(k) clearance on 2019-10-08 under approval number K191448. 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 Barrier Sleeves?
Barrier Sleeves is a medical device that received FDA 510(k) clearance on 2019-10-08. It is manufactured by Ivoclar Vivadent, AG. The 510(k) number is K191448.
When was Barrier Sleeves approved by the FDA?
Barrier Sleeves received FDA 510(k) clearance on 2019-10-08, under approval number K191448.
What company makes Barrier Sleeves?
Barrier Sleeves is manufactured by Ivoclar Vivadent, AG.
What is the FDA product code for Barrier Sleeves?
The FDA product code for Barrier Sleeves is PEM.
Other Devices by Ivoclar Vivadent, AG
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K190484BH Medical Dental Barrier Sleeves and Barrier FilmBh Medical Products Co., Ltd.
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K183263UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier EnvelopeUnipack Medical 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.