Hygienic Protective Bite Cover (2207-010-50)

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION September 17, 2026 Dürr Dental SE Corinna Gordillo Regulatory Affairs Manager Höpfigheimer St. 17 Bietigheim-Bissingen, BW 74321 Germany Re: K262073 Trade/Device Name: Hygienic Protective Bite Cover (2207-010-50) Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape And Drape Accessories Regulatory Class: Class II Product Code: PEM, Dated: June 19, 2026 Received: June 22, 2026 Dear Corinna Gordillo: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K262073 - Corinna Gordillo Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- {2} K262073 - Corinna Gordillo Page 3 assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely,  For Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} # Indications for Use | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | | K262073 | ? | | --- | --- | --- | --- | | Please provide the device trade name(s). | | | ? | | Hygienic Protective Bite Cover (2207-010-50) | | | | | Please provide your Indications for Use below. | | | ? | | Hygienic protective covers serve as hygienic barrier between dental instruments, equipment, accessories, and patient during use. The device is non-sterile and intended for single patient use only. | | | | | Please select the types of uses. | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | ? | | Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☑ Children (2 years old to < 12 years old) ☑ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | | ? | {4} DÜRR DENTAL # 510(k) SUMMARY (In accordance with 21 CFR 807.92) K262073 # Hygienic Protective Bite Cover DÜRR DENTAL SE Höpfigheimer Str. 17 74321 Bietigheim-Bissingen Germany 1. Date Summary Prepared May 29, 2026 2. Submitter's Information • Company: DÜRR DENTAL SE • Role: Manufacturer • Owner/Operator No.: 10047925 • Establishment Reg. No.: 3015509619 • Address: Höpfigheimer Str. 17 74321 Bietigheim-Bissingen Germany • Website: www.duerrdental.com • Phone: +49 7142 70 5-0 • Responsible Person: Oliver Lange Director Quality Management oliver.lange@duerrdental.com +49 7142 705-190 • Submission Correspondent: Corinna Gordillo Regulatory Affairs Manager corinna.gordillo@duerrdental.com 3. Type of Submission • 510(k): Traditional 510(k) • Purpose of this submission: Initial Submission 1 {5} DÜRR DENTAL #### 4. Subject Device • Trade/Device Name: Hygienic Protective Bite Cover • Manufacturer: DÜRR DENTAL SE • Classification Name: Surgical Drape and Drape Accessories • Regulation Number: 21 CFR 878.4370 • Regulatory Class: Class II • Product Code: PEM #### 5. Predicate Device • Trade/Device Name: Dental Barrier and Sleeves • Manufacturer: Yueying Medical Instruments (Langfang) Co., Ltd • 510(k) Number: K250606 • Classification Name: Surgical Drape and Drape Accessories • Regulation Number: 21 CFR 878.4370 • Regulatory Class: Class II • Product Code: PEM #### 6. Indications for Use Hygienic protective covers serve as hygienic barrier between dental instruments, equipment, accessories, and patient during use. The device is non-sterile and intended for single patient use only. #### 7. Device Description The hygienic protective bite cover is a disposable polyethylene cover designed to function as a hygienic barrier between patient and dental devices or device components. It is intended to prevent direct contact and reduce the risk of contamination during dental diagnostic procedures. The cover is supplied non-sterile and is intended for single use only. | Product Family | Trade Name | Reference Number (REF) | Application | | --- | --- | --- | --- | | VistaVox / VistaPano | Hygienic Protective Bite Cover | 2207-010-50 | Cover for bite block | Prior to dental extraoral radiological examinations (like OPG or CBCT), the hygienic protective bite cover is placed over the bite block and remains in position for the duration of the examination. It serves as a disposable hygienic barrier, preventing direct contact between the bite block and the patient's oral cavity. The use of the hygienic protective bite cover is recommended but not mandatory to reduce the risk of cross-contamination, as the bite block is positioned intraorally. The bite block may be used with or without hygienic protective bite cover, as it is designed to be reusable and can be reprocessed in accordance with validated cleaning, sterilization and disinfection procedures (as described in the instruction for use). 2 {6} DÜRR DENTAL ### 8. Substantial Equivalence Comparison Shown below are the technological characteristics of the subject device compared with the predicate device. | Device | Subject Device | Predicate Device | Comparison | | --- | --- | --- | --- | | Manufacturer | DÜRR DENTAL SE | Yueying Medical Instruments (Langfang) Co., Ltd | / | | 510(k) Number | - | K250606 | / | | Product Name | Hygienic Protective Bite Cover | Dental Barrier and Sleeves | / | | Classification | Class II Device (21 CFR 878.4370) | Class II Device (21 CFR 878.4370) | Same | | Product Code | PEM | PEM | Same | | Device Reference No. | 2207-010-50 | Refer to K250606 | / | | Indications for Use | Hygienic protective covers serve as hygienic barrier between dental instruments, equipment, accessories, and patient during use. The device is non-sterile and intended for single patient use only. | Dental Barrier and Sleeves are intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only | The intended use of both product types is equivalent. | | Device Description | The hygienic protective bite cover is a polyethylene protective sleeve designed to be placed over the bite block during dental radiological examinations. The cover is supplied non-sterile, prepackaged and is intended for single use only. | Dental Barrier and Sleeves consist of various sizes and shapes of polyethylene covers which are positioned on various small hand-held dental instruments such as hand pieces, curing lights, air/water syringes and similar hand instruments. In other forms, they are used to cover various devices such as dental chairs, dental instrument trays, x-ray heads, and others. The products are sold non-sterile, prepackaged, and are disposable, single use only. | The intended use of both product types is equivalent. The predicate device also includes covers for intraoral use, such as bite block covers, as does the subject device. | | Sterility | Non-sterile | Non-sterile | Same | | Labeling | Single-use device | Single-use device | Same | 3 {7} DÜRR DENTAL | Device | Subject Device | Predicate Device | Comparison | | --- | --- | --- | --- | | Technology/Function | Passive dental barrier/sleeve used to cover equipment. | Passive dental barrier/sleeve used to cover equipment. | Same fundamental barrier technology. | | Material | Polyethylene film | Polyethylene film | Equivalent material class. | | Material Composition | LDPE XSF-68.3 | LLDPE (80%), LDPE (20%) | Equivalent material class. | | Performance Properties | - Synthetic Blood Penetration test (ASTM F1670) - Viral Penetration test (ASTM F1671) | - Synthetic Blood Penetration test (ASTM F1670) - Viral Penetration test (ASTM F1671) | Same | | Biocompatibility | - Non-cytotoxic - Non-sensitizing - Non-irritating | - Non-cytotoxic - Non-sensitizing - Non-irritating | Equivalent. All devices meet the ISO 10993 requirements for contact duration and exposure. | | Dimensions | One size only. | Multiple barrier sleeve sizes available. Difference in dimensions is due to the size of instruments and equipment they cover. | Differences are dimensional only. Not safety-critical. | | FDA recognized Standards | ASTM F1670 ASTM F1671 ASTM D882 ASTM F1342 ASTM D1004 ISO 10993-1 ISO 10993-5 ISO 10993-10 | ASTM F1670 ASTM F1671 ASTM D882 ASTM F1342 ASTM D1004 ISO 10993-5 ISO 10993-10 ISO 10993-23 | Equivalent | ### Substantial Equivalence Discussion The subject device and the predicate device share the same intended use. Both are single-use devices and are equivalent with respect to materials and performance characteristics. Compared to the subject device, the predicate device also includes intraoral accessories such as bite block covers. Subject and predicate device share the same fundamental barrier technology, and the material class is equivalent. Minor specification differences or differences in dimensions between the subject and predicate devices do not introduce new questions of safety or effectiveness and are deemed not safety-critical. 4 {8} DÜRR DENTAL ## 9. Non-Clinical Testing ### 9.1 Biocompatibility Testing Non-clinical performance testing demonstrated that the subject device met all predefined acceptance criteria for the applicable standard tests performed. The testing strategy, rationales and test reports are documented in the attached “*Biological Risk Assessment*” document. Refer to: | Topic | Standard ID | Submission Attachment | | --- | --- | --- | | **Biological Risk Assessment** | ISO 10993-1 | 08_Biological Risk Assessment.pdf | | **Cytotoxicity** | ISO 10993-5 | 08_Biological Risk Assessment.pdf | | **Sensitization** | ISO 10993-10 | 08_Biological Risk Assessment.pdf | | **Irritation** | ISO 10993-10 | 08_Biological Risk Assessment.pdf | ### 9.2 Performance Testing Non-clinical performance testing demonstrated that the material of the subject device meets the predefined acceptance criteria for the applicable standard tests. The covers are made of a transparent polyethylene material that has been demonstrated to be safe and effective through more than 20 years of use. The material was successfully cleared as part of the approval of another product line from our subsidiary (see K190949, ScanX Barrier Envelopes). A rationale supporting the relevance and applicability of these test reports to the subject device is provided in the attached “*Performance Testing Assessment*” document. Refer to: | Topic | Standard ID | Submission Attachment | | --- | --- | --- | | **Performance Testing Assessment** | / | 09_Performance Testing Assessment.pdf | | **Tear Resistance** | ASTM D1004 | 09_Performance Testing Assessment.pdf | | **Tensile Strength** | ASTM D882 | 09_Performance Testing Assessment.pdf | | **Synthetic Blood Penetration** | ASTM F1670 | 09_Performance Testing Assessment.pdf | | **Viral Penetration** | ASTM F1671 | 09_Performance Testing Assessment.pdf | | **Puncture Resistance** | ASTM F1342 | 09_Performance Testing Assessment.pdf | 5 {9} DÜRR^{}[] DENTAL ## **10. Shelf-Life** Not applicable. The device is supplied non-sterile and intended for single-use; therefore, no shelf-life evaluation is required. ## **11. Clinical Data** Not applicable. No clinical studies are required to support the safety or performance of the device. ## **12. Conclusion** Based on the comparison and analysis above, the subject device is as safe, as effective, and performs as well as the legally marketed predicate devices. 6