Dental Barriers and Sleeves (AB0006)

{0} **FDA U.S. FOOD & DRUG** ADMINISTRATION September 8, 2026 ANI Co., Ltd. % Bobae Jung General Manager JNM KOREA CO.,Ltd 206, 207, 306, Gunpo-It Valley 17 Gosan-Ro 14beon-Gil Gunpo-Si, Gyeonggi-Do, 15850 REPUBLIC OF KOREA Re: K261956 Trade/Device Name: Dental Barriers and Sleeves (AB0006) Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape And Drape Accessories Regulatory Class: Class II Product Code: PEM Dated: June 11, 2026 Received: June 11, 2026 Dear Bobae Jung: 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} K261956 - Bobae Jung 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 {2} K261956 - Bobae Jung Page 3 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-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, MICHAEL E. ADJODHA -S 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. | | K261956 | ? | | --- | --- | --- | --- | | Please provide the device trade name(s). | | | ? | | Dental Barriers and Sleeves (AB0006) | | | | | Please provide your Indications for Use below. | | | ? | | The Dental Barriers and Sleeves are intended to be used as a barrier to cover dental instruments. This device is non-sterile and is intended for single patient use only. | | | | | Please select the types of uses (select one or both, as applicable). | ☐ 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} ANI CO., LTD. Dental Barriers and Sleeves # SECTION 05 # 510(k) SUMMARY K261956 SECTION 05 page 1 / 5 {5} ANI CO., LTD. Dental Barriers and Sleeves K261956 This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92. # I. Date 510k summary prepared: 18, 05, 2026 # II. SUBMITTER | Submitter's Name | ANI Co., Ltd. | | --- | --- | | Submitter's Address | 4F, Building B, 182, Saneop-ro 156beon-gil, Gwonseon-gu, Suwon-si, Gyeonggi-do, 16648, Republic of Korea | | Submitter's Telephone | +82 31-5186-7613 | | Contact person | Seongcheol, Kim | | E-mail | sckim@anieng.com | | Telephone | +82 31-5186-7613 | | Fax: | +82 31-5186-7685 | # III. DEVICE | Trade/proprietary Name | Dental Barriers and Sleeves | | --- | --- | | Common or Usual Name | Dental Barriers and Sleeves | | Regulation Name | Surgical drape and drape accessories | | Regulation Number | 21 CFR 878.4370 (Product Code: PEM) | | Regulatory Class | Class II | # IV. PREDICATE DEVICE # 1) Predicate device No. 1 | Primary Manufacturer | TIDI Products, LLC | | --- | --- | | Device Name | TIDIShield Curing Light Sleeve | | 510(k) Number | K132953 | | Regulation Name | Dental Barriers and Sleeves | | Regulation Number | 21 CFR 878.4370 | | Regulatory Class | Class II | SECTION 05 page 2 / 5 {6} ANI CO., LTD. Dental Barriers and Sleeves # 2) Predicate device No. 2 | Primary Manufacturer | DENTSPLY International | | --- | --- | | Device Name | Dental Barriers and Sleeves | | 510(k) Number | K160232 | | Regulation Name | Surgical Drape and Drape Accessories | | Regulation Number | 21 CFR 878.4370 | # V. DEVICE DESCRIPTION The Dental Barrier and Sleeve is a disposable, single-use protective cover designed for use with intraoral devices such as dental intraoral cameras, dental curing light, Dental Intraoral Scanner and Fluorescence-based Caries Detection Device equipment. It acts as a physical barrier to help prevent cross-contamination between patients during clinical procedures. # VI. INDICATIONS FOR USE: Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients SECTION 05 page 3 / 5 {7} ANI CO., LTD. Dental Barriers and Sleeves ### VII. SUBTANTIALLY EQUIVALENT (SE) COMPARISON CHART Subject device is substantially equivalent to TIDIShield Curing Light Sleeve (K132953) and Disposable Barries Sleeves and Covers (K160232). The following comparison table is presented to demonstrate substantial equivalence. | Category | Subject Device | Predicate Device #1 | Predicate Device #2 | Remark | | --- | --- | --- | --- | --- | | 510(k) Number | - | K132953 | K160232 | Not applicable | | Product Code | PEM | PEM | PEM | SE | | Regulation Number | 21 CFR 878.4370 | 21 CFR 878.4370 | 21 CFR 878.4370 | SE | | Class | II | II | II | SE | | Device Category | Dental Barriers and Sleeves | Dental Barriers and Sleeves | Dental Barriers and Sleeves | SE | | Regulation description | Surgical drape and drape accessories | Surgical drape and drape accessories | Surgical drape and drape accessories | SE | | Intended use | Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients | The TIDiShield Curing Light Sleeves are indicated for use as a barrier that is used as an accessory to dental instrument. These sleeves are non-sterile and are intended for single patient use only | Disposable Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only. See the attached table for the product names, trade names and model numbers. | SE | | Material | Polyethylene film | Polyethylene film | Polyethylene film | SE | | Composition of Material | LLDPE (100%) | LLDPE (80%) LDPE (20%) | LLDPE LDPE | Similar | | Sterility | Non-Sterile | Non-Sterile | Non-Sterile | SE | | Labeling | Single Use Only | Single Use Only | Single Use Only | SE | | Specifications | · Film Thickness: 0.03mm | · Paper backing: Yes · Film thickness: 0.02mm · Tolerance: <0.01mm | · Film thickness: 0.02 mm, 0.03 mm, 0.05 mm | SE | | Performance Properties | · Synthetic Blood Penetration (ASTM F1670) - Pass · Viral Penetration (ASTM F1671) - Pass | · Synthetic Blood Penetration (ASTM F1670) - Pass · Viral Penetration (ASTM F1671) - Pass | · Synthetic Blood Penetration (ASTM F1670) - Pass · Viral Penetration (ASTM F1671) - Pass | SE | | Mechanical Properties | · Tensile Strength: 0.03 mm - Acceptable · Puncture Resistance: 0.03 mm - Acceptable · Tear Resistance: 0.03 mm - Acceptable | · Tensile Strength: 0.05 mm - Acceptable · Puncture Resistance: 0.05 mm - Acceptable · Tear Resistance: 0.05 mm - Acceptable | · Tensile Strength: 0.02 mm - Acceptable 0.03 mm - Acceptable 0.05 mm - Acceptable · Puncture Resistance: 0.02 mm - Acceptable 0.03 mm - Acceptable 0.05 mm - Acceptable · Tear Resistance: 0.02 mm - Acceptable 0.03 mm - Acceptable 0.05 mm - Acceptable | SE | SECTION 05 page 4 / 5 {8} ANI CO., LTD. Dental Barriers and Sleeves | Biocompatibility | Biocompatibility tests were conducted in compliance with ISO 10993-5, ISO 10993-10 and ISO 10993-23. Test results indicate the device is non-cytotoxic, non-sensitizing and non-irritating. | Non-cytotoxic Non-sensitizing Non-irritating | Non-cytotoxic Non-sensitizing Non-irritating | SE | | --- | --- | --- | --- | --- | | FDA-Recognized Standards | ASTM F1670 ASTM F1671 ASTM D882 ASTM F1342 ASTM D1004 ISO 10993-5 ISO 10993-10 ISO 10993-23 | ASTM F1670 ASTM D1004 ASTM D882 ASTM F1342 | ASTM F1670 ASTM F1671 ASTM D882 ASTM F1342 ASTM D1004 ISO 10993-5 ISO 10993-10 ISO 10993-23 | SE | Based on performance testing, biocompatibility testing, and comparison to predicate devices, the subject device is substantially equivalent to the previously cleared predicate device. ### VII. Summary of Non-Clinical Testing Biocompatibility test in accordance with ISO 10993-5, ISO 10993-10, and ISO 10993-23 has been performed. | Biocompatibility Test | Summary | | | | | --- | --- | --- | --- | --- | | | Methodology | Purpose | Acceptable Criteria | Results | | In-Vitro Cytotoxicity | Study conducted in compliance to ISO 10993-5:2009. Test and/or control article prepared in compliance to ISO 10993-12:2021. | This study is to evaluate whether the extract from the contact surface of the test article [Dental Barriers and Sleeves] exhibits cytotoxicity using L-929 cells. | Acceptable criteria per ISO 10993-5 | Test article passed test and determined non-cytotoxic | | Sensitization | Study conducted in compliance to ISO 10993-10:2021. Test and/or control article prepared in compliance to ISO 10993-12:2021. | This study is conducted using guinea pigs to evaluate the skin sensitization potential of the test article. | Acceptable criteria per ISO 10993-10 | Test article considered non-sensitizer. | | Irritation | Study conducted in compliance to ISO 10993-23:2021. Test and/or control article prepared in compliance to ISO 10993-12:2021. | This study evaluates oral mucosal irritation of the test article using Syrian hamsters. | Acceptable criteria per ISO 10993-23 | Test article considered non-irritant | The biocompatibility test results indicate that the subject device does not have the potential for cytotoxicity, SECTION 05 page 5 / 5 {9} ANI CO., LTD. Dental Barriers and Sleeves sensitization, or oral mucosal irritation. Performance and mechanical property test including resistance to penetration, tear resistance, tensile strength, puncture resistance was performed. | Performance Test | Summary | | | | | --- | --- | --- | --- | --- | | | Methodology | Purpose | Acceptable Criteria | Results | | ASTM F1670 | Study conducted per ASTM F1670/F1670M-25. | This study evaluates resistance of protective materials to penetration by synthetic blood under conditions of continuous liquid contact. | Acceptable criteria per ASTM F1670 | Pass | | ASTM F1671 | Study conducted per ASTM F1671:20205. | This study evaluates barrier performance of protective materials which are intended to protect against blood borne pathogen hazard. | Acceptable criteria per ASTM F1671 | Pass | | Mechanical Property | Summary | | | | | --- | --- | --- | --- | --- | | | Methodology | Subject Device | Predicate Device #1 | Predicate Device #2 | | ASTM D882 | Study conducted per ASTM D882-18 | 0.03 mm Acceptable | 0.05 mm Acceptable | 0.02 mm Acceptable 0.03 mm Acceptable 0.05 mm Acceptable | | ASTM D1004 | Study conducted per ASTM D1004-21 | 0.03 mm Acceptable | 0.05 mm Acceptable | 0.02 mm Acceptable 0.03 mm Acceptable 0.05 mm Acceptable | | ASTM F1342 | Study conducted per ASTM F1342/F1342M-05 (2022) | 0.03 mm Acceptable | 0.05 mm Acceptable | 0.02 mm Acceptable 0.03 mm Acceptable 0.05 mm Acceptable | SECTION 05 page 6 / 5 {10} ANI CO., LTD. Dental Barriers and Sleeves The range of mechanical properties for the samples of the subject device are comparable to those reported for the predicate devices and support substantial equivalence with the predicate devices. ### VIII. Animal Study No animal studies were considered necessary and performed. ### IX. Clinical Study No Clinical Studies were considered necessary and performed. ### X. Conclusion The subject and predicate devices have the same intended use. They are single-use devices, and material and performance characteristics are similar. The minor differences in specifications between the subject and predicate devices do not raise new safety and effectiveness issues. SECTION 05 page 7 / 5