Cleared Traditional

K262073 - Hygienic Protective Bite Cover (2207-010-50)

K262073 is an FDA 510(k) clearance for Hygienic Protective Bite Cover (2207-01..., manufactured by D?rr Dental SE. The device is a Class 2 Dental device with product code PEM cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K262073 · D?rr Dental SE · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
87d
Days
Class 2
Risk

K262073 is an FDA 510(k) clearance for the Hygienic Protective Bite Cover (2207-010-50). Classified as Dental Barriers And Sleeves (product code PEM), Class II - Special Controls.

Submitted by D?rr Dental SE (Bietigheim-Bissingen, DE). The FDA issued a Cleared decision on September 17, 2026 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 878.4370 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all D?rr Dental SE devices

FDA 510(k) Submission Details - K262073

510(k) Number K262073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2026
Decision Date September 17, 2026
Days to Decision 87 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 128d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PEM Device Classification - Class 2, Special Controls

Product Code PEM Dental Barriers And Sleeves
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
Definition Intended To Serve As A Disposable Barrier For Dental Instruments To Reduce The Risk Of Cross Contamination Between Dental Patients.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - PEM Dental Barriers And Sleeves

All 16
Devices cleared under the same product code (PEM) and FDA review panel - the closest regulatory comparables to K262073.
Dental Barriers and Sleeves (AB0006)
K261956 · ANI Co., Ltd. · Sep 2026
Dental Barrier and Sleeves
K250735 · Fomed Industries, Inc. · Jun 2025
Dental Barrier and Sleeves
K250606 · Yueying Medical Instruments (Langfang) Co., Ltd. · May 2025
Dental Barrier and Sleeves
K242435 · Wellmed Dental Medical Supply Co., Ltd. · Oct 2024
Dental Barrier and Sleeves
K233918 · Yongqing Huaguan Dental Instruments Factory · May 2024
Disposable Barrier Sleeves
K220662 · Premium Plus (Dongguan) Limited · May 2022