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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, AG. It received FDA 510(k) clearance on 2019-10-08 under 510(k) 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. The listed applicant is Ivoclar Vivadent, AG. The 510(k) number is K191448.

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

Barrier Sleeves received FDA 510(k) clearance on 2019-10-08, under 510(k) number K191448.

Who is the listed applicant for Barrier Sleeves?

The FDA 510(k) record lists Ivoclar Vivadent, AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Barrier Sleeves?

The FDA product code for Barrier Sleeves is PEM.

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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

View on FDA Database →

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

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