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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Dentsply International, Inc.. It received FDA 510(k) clearance on 2016-06-07 under 510(k) 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. The listed applicant is Dentsply International, Inc.. The 510(k) number is K160232.

When did Disposable Barrier Sleeves and Covers receive FDA 510(k) clearance?

Disposable Barrier Sleeves and Covers received FDA 510(k) clearance on 2016-06-07, under 510(k) number K160232.

Who is the listed applicant for Disposable Barrier Sleeves and Covers?

The FDA 510(k) record lists Dentsply International, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Dentsply International, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K160207ATLANTIS ISUS Implant SuprastructuresK151439ATLANTIS ISUSK152247ATLANTIS CrownK151039ATLANTIS Abutment for NobelActive 3.0

Related Devices (Code: PEM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250735Dental Barrier and SleevesFomed Industries, Inc.K250606Dental Barrier and SleevesYueying Medical Instruments (Langfang) Co., Ltd.K242435Dental Barrier and SleevesWellmed Dental Medical Supply Co., Ltd.K233918Dental Barrier and SleevesYongqing Huaguan Dental Instruments FactoryK220662Disposable Barrier SleevesPremium Plus (Dongguan) LimitedK211026Minitube Dentasleeve Protective Barrier SleevesMinitube AB

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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