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FDA 510(k)

Plasdent Disposable Barrier Sleeves and Barrier Film

K-Number: K201604 · 2020-12-23

ApplicantPlasdent Corporation
Decision Date2020-12-23
Product CodePEM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Plasdent Disposable Barrier Sleeves and Barrier Film is the device name listed in this FDA 510(k) record. The listed applicant is Plasdent Corporation. It received FDA 510(k) clearance on 2020-12-23 under 510(k) number K201604. 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 Plasdent Disposable Barrier Sleeves and Barrier Film?

Plasdent Disposable Barrier Sleeves and Barrier Film is a medical device that received FDA 510(k) clearance on 2020-12-23. The listed applicant is Plasdent Corporation. The 510(k) number is K201604.

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

Plasdent Disposable Barrier Sleeves and Barrier Film received FDA 510(k) clearance on 2020-12-23, under 510(k) number K201604.

Who is the listed applicant for Plasdent Disposable Barrier Sleeves and Barrier Film?

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

What is the FDA product code for Plasdent Disposable Barrier Sleeves and Barrier Film?

The FDA product code for Plasdent Disposable Barrier Sleeves and Barrier Film 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) 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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