Disposable Barrier Sleeves and Covers
K-Number: K160232 · 2016-06-07
ApplicantDentsply International, Inc.
Decision Date2016-06-07
Product CodePEM
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Disposable Barrier Sleeves and Covers is a medical device manufactured by Dentsply International, Inc.. It received FDA 510(k) clearance on 2016-06-07 under approval number K160232. 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 Disposable Barrier Sleeves and Covers?
Disposable Barrier Sleeves and Covers is a medical device that received FDA 510(k) clearance on 2016-06-07. It is manufactured by Dentsply International, Inc.. The 510(k) number is K160232.
When was Disposable Barrier Sleeves and Covers approved by the FDA?
Disposable Barrier Sleeves and Covers received FDA 510(k) clearance on 2016-06-07, under approval number K160232.
What company makes Disposable Barrier Sleeves and Covers?
Disposable Barrier Sleeves and Covers is manufactured by Dentsply International, Inc..
What is the FDA product code for Disposable Barrier Sleeves and Covers?
The FDA product code for Disposable Barrier Sleeves and Covers is PEM.
Other Devices by Dentsply International, Inc.
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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.