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FDA 510(k)

Minitube Dentasleeve Protective Barrier Sleeves

K-Number: K211026 · 2021-08-03

ApplicantMinitube AB
Decision Date2021-08-03
Product CodePEM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Minitube Dentasleeve Protective Barrier Sleeves is the device name listed in this FDA 510(k) record. The listed applicant is Minitube AB. It received FDA 510(k) clearance on 2021-08-03 under 510(k) number K211026. 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 Minitube Dentasleeve Protective Barrier Sleeves?

Minitube Dentasleeve Protective Barrier Sleeves is a medical device that received FDA 510(k) clearance on 2021-08-03. The listed applicant is Minitube AB. The 510(k) number is K211026.

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

Minitube Dentasleeve Protective Barrier Sleeves received FDA 510(k) clearance on 2021-08-03, under 510(k) number K211026.

Who is the listed applicant for Minitube Dentasleeve Protective Barrier Sleeves?

The FDA 510(k) record lists Minitube AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Minitube Dentasleeve Protective Barrier Sleeves?

The FDA product code for Minitube Dentasleeve Protective Barrier Sleeves is PEM.

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) LimitedK201604Plasdent Disposable Barrier Sleeves and Barrier FilmPlasdent 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.

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