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FDA 510(k)

Hygienic Protective Bite Cover (2207-010-50)

K-Number: K262073 · 2026-09-17

ApplicantDürr Dental SE
Decision Date2026-09-17
Product CodePEM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Hygienic Protective Bite Cover (2207-010-50) is the device name listed in this FDA 510(k) record. The listed applicant is Dürr Dental SE. It received FDA 510(k) clearance on 2026-09-17 under 510(k) number K262073. 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 Hygienic Protective Bite Cover (2207-010-50)?

Hygienic Protective Bite Cover (2207-010-50) is a medical device that received FDA 510(k) clearance on 2026-09-17. The listed applicant is Dürr Dental SE. The 510(k) number is K262073.

When did Hygienic Protective Bite Cover (2207-010-50) receive FDA 510(k) clearance?

Hygienic Protective Bite Cover (2207-010-50) received FDA 510(k) clearance on 2026-09-17, under 510(k) number K262073.

Who is the listed applicant for Hygienic Protective Bite Cover (2207-010-50)?

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

What is the FDA product code for Hygienic Protective Bite Cover (2207-010-50)?

The FDA product code for Hygienic Protective Bite Cover (2207-010-50) is PEM.

Other records listing Dürr Dental SE 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.

K203287DBSWIN, VISTAEASYK202633ScanX Edge

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.

K261956Dental Barriers and Sleeves (AB0006)ANI Co., Ltd.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) Limited

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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