VPS Impression Material

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. April 19, 2021 Hygedent, Inc. Peng Wang General Manager Room 210C, Building 4, No 5 Chaoqian Road Beijing, 102299 CHINA Re: K203824 Trade/Device Name: VPS Impression Material Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: January 25, 2021 Received: January 25, 2021 Dear Peng Wang: 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 (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 located 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. 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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, M.ChE. Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K203824 Device Name VPS Impression Marterial Indications for Use (Describe) VPS Impression Material(Light Body) is to be used as syringeable impression materials for: -Two-step putty-wash impression technique; -One-step putty-wash impression technique; - Two-step impression technique using dual viscosities ; - Reline impressions ; -Fabricating full or partial dentures; | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # Chapter 6 510(k) Summary (K203824) In accordance with 21 CFR 807.92 the following summary of information is provided: | Date: | 04/16/2021 | |---------------------------------------|-------------------------------------------------------------------------------------------------------------| | Submitter: | HYGEDENT INC | | Add: | Room 210C, Building 4, No 5 Chaoqian Road, Science Industry<br>Park, Changping District, Beijing, P.R.China | | Establishment<br>Registration Number: | 3011187729 | | Owner/Operator<br>Number: | 10047045 | | Primary Contact<br>Person: | Peng Wang (General Manager) | | | HYGEDENT INC. | | | Tel: +85-13901284956 | | | Email: zoe.sun@hygedent.com | | US Agent: | Zoe | | | HYGEDENT DENTAL INC. | | | 11622 El Camino Real, Suite 100, San Diego, CA 92130 | | | Phone: 858 764 2495 | | | Email: zoesunyi@yahoo.com | | Device:Trade Name:<br>Type: | VPS Impression Material<br>Light | | Common/Usual<br>Name: | Impression Material | | Classification Names: | Material, Impression | | Regulation number: | 21 CFR 872.3660 | | Product Code: | ELW | | Regulation Class: | 2 | | Predicate Device(s): | K192941 (Primary Predicate): Osstem Implant Co.,Ltd. | {4}------------------------------------------------ | Device Description: | K203824:VPS Impression Material is dental Impression Material. It<br>complies with the requirements of ISO 4823:2015 for dental elastomeric<br>impression materials. It is supplied as atwo-part base/catalyst<br>formulation preloaded in a dual-barrel cartridge. The VPS Impression<br>Material package includes four dual-barrel 50ml cartridges. | |----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use: | K203824: VPS Impression Material(Light Body) is to be used as<br>syringeable impression materials for:<br>-Two-step putty-wash impression technique;<br>-One-step putty-wash impression technique;<br>- Two-step impression technique using dual viscosities ;<br>- Reline impressions : | -Fabricating full or partial dentures; # Substantial Equivalence Matrix : | | Proposed Device | Primary Predicate Device | Remark | |----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | VPS Impression Material | HySil Super Fast Impression<br>Materials | Different | | Type | Light | Heavy, Mono, Light | Different | | 510(k) No. | K203824 | K192941 | Different | | Manufacturer | HYGEDENT INC | Osstem Implant Co.,Ltd. | Different | | Indications<br>for Use: | VPS Impression Material<br>(Light Body) is to be used<br>as syringeable impression<br>materials for:<br>-Two-step putty-wash<br>impression technique;<br>-One-step putty-wash<br>impression technique;<br>- Two-step impression | HySil Heavy Super Fast is to be<br>used as heavy-bodied materials for:<br>- One-step impression technique<br>using single or dual viscosities;<br>- Two-step impression technique<br>using dual viscosities<br>- Functional impressions<br>HySil Mono Super Fast is to be<br>used as a medium bodied tray or | Different since the<br>predicate devices<br>have 3 types of<br>devices (Heavy,<br>Mono,Light),<br>while the proposed<br>devices have 1type | | | | | | | technique using dual | syringeable impression material for: of devices . | | | | viscosities ; | - Taking impressions over | Although there are | | | - Reline impressions ; | removable/ fixed restorations and differences in | | | | - Fabricating full or | - implants | number of types, | | | partial dentures; | - Functional impressions | the Indications for | | | | - Fabricating crown and bridgework | | | | | or inlays | Use Statements of<br><b>Light type</b> for | | | | - Fabricating full or partial dentures | both proposed and | | | | - Reline impressions | predicate devices | | | | - Use in the simultaneous mixing | are same. | | | | technique as well as the putty- | | | | | wash and triple tray techniques | | | | | - Transferring root posts when | | | | | fabricating posts and cores | | | | | indirectly | | | | | <b>HySil Light Super Fast</b> is to be | | | | | used as syringeable impression | | | | | materials for: | | | | | - Two-step putty-wash impression | | | | | technique; | | | | | - One-step putty-wash impression | | | | | technique; | | | | | - Two-step impression technique | | | | | using dual viscosities ; | | | | | - Reline impressions ; | | | | | - Fabricating full or partial | | | | | dentures; | | | | | | | | | | - Be placed on an<br>impression tray (or<br>injected directly into<br>the mouth, depending<br>on the technique and<br>device) and used to<br>reproduce the structure<br>of a patient's teeth and<br>gums<br>- Provide models for study<br>and for production of<br>restorative prosthetic<br>devices | - Be placed on an impression tray<br>(or injected directly into the<br>mouth, depending on the<br>technique and device) and used<br>to reproduce the structure of a<br>patient's teeth and gums<br>- Provide models for study and<br>for production of restorative<br>prosthetic devices | Same | | Principle of<br>Operation | | | | | Description of<br>Material | Vinylpolysiloxane | Vinylpolysiloxane | Compose with<br>same affiliated<br>material, but<br>ratios of each<br>component in<br>use are different | | Standard<br>Conformed | ISO 4823 | ISO 4823 | Same | | Working Time | 1 min. 30 sec. | Over 1 min. 15 sec | Proposed devices<br>have longer<br>working time | | Shelf-life | 2 years | 2 years | Same | Page 6-2 {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ #### Similarities: S.E The proposed devices and the predicated devices are made with same affiliated material called Vinylpolysiloxane conformed to ISO 4823 standard. Both are in 50ml cartridge with base and catalyst ratio of 1 to 1; have same indications for use; have same principle of operation; and have same shelf-life. #### Differences Compared to the predicated devices, the proposed devices have different composition ratios which results in longer working time. However, based on the results of the performance and the biocompatibility testing, the proposed and the predicated devices both passed the requirements. Also, there are differences in Indications for Use Statement since the predicated devices have 3 types of devices, Heavy, Mono and Light while the proposed devices have 1 types of devices. Although there are differences in number of types, the Indications for Use Statements of Light type for both proposed and predicated devices are same. Thus, the differences in Indications for Use Statement do not affect the substantial equivalence of proposed devices. Therefore, we stated that proposed devices (VPS Light Impression Materials) are substantially equivalent to the predicated devices (HySil Light Super Fast Impression Materials) cleared in K192941. #### Summary of Non-Clinical Tests: Performance testing was conducted to validate and verify that the proposed device met all design specifications and was substantially equivalence to the predicate device. Results of performance testing indicate that the grounding pad meets applicable sections of the standards referenced and are sufficient for their intended use. The subject of this premarket submission, VPS Impression Material did not require clinical studies to support substantial equivalence. {8}------------------------------------------------ ## Biocompatibility: VPS Impression Material, the proposed device and predicate device contacts directly with the oral mucosa (3-5 minutes). The duration of contact is less than 24hours, therefore they are categorized as surface contact devices with limited contact duration. Testing was Performed for Cytotoxicity (ISO 10993-5 ), Sensitization and Irritation( ISO 10993-10). The test results demonstrate that the proposed device VPS Impression Material is as biocompatible as the predicate device. ## Conclusion: The technical characteristics, material composition, principles of operation and indications for use of the proposed device VPS impression Material is comparable to the predicate device. The few differences do not affect the safety and effectiveness of the proposed device. Therefore, Hygedent Inc. considers that VPS Impression Material is substantially equivalent to the predicate device.