Hygienic Protective Bite Cover (2207-010-50)— 510(k) K262073
Substantially EquivalentDürr Dental SE
FDA 510(k) clearance K262073 for Hygienic Protective Bite Cover (2207-010-50), Substantially Equivalent on 2026-09-17. Applicant: Dürr Dental SE. Device class: 2.
Summary
Hygienic Protective Bite Cover (2207-010-50) is from Dürr Dental SE, filed under product code PEM (Dental Barriers And Sleeves). The record gives the catalog number and nothing more.
Class II, 21 CFR 878.4370. The Dental review panel handled it as a Traditional 510(k), though the record lists General, Plastic Surgery as the classification panel. The decision was Substantially Equivalent.
Dürr Dental filed from Bietigheim-Bissingen, Germany. The decision came 87 calendar days after FDA received it (June 22 to September 17, 2026).
Clearance details
- Applicant
- Dürr Dental SE
- Product code
- Product code PEM
- Device class
- Class 2
- Regulation
- 21 CFR 878.4370
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bietigheim-Bissingen, DE
Recent devices under product code PEM
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