HySil Super Fast Impression Materials

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line. January 30, 2020 Osstem Implant Co., Ltd. % Peter Lee QA/RA Manager Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030 Re: K192941 Trade/Device Name: HySil Super Fast Impression Materials Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: November 4, 2019 Received: November 5, 2019 Dear Peter Lee: 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, for Srinivas "Nandu" Nandkumar 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}------------------------------------------------ ### 510(k) Number: K192941 ### Device Name: HySil Super Fast Impression Materials ### Indications for Use: HySil Heavy Super Fast is to be used as heavy-bodied materials for: - One-step impression technique (simultaneous technique) using single or dual viscosities - - Two-step impression technique using dual viscosities - - Functional impressions - HySil Mono Super Fast is to be used as a medium-bodied tray or syringeable impression material for: - Taking impressions over fixed/removable restorations and implants -(i.e., transferring impressi on posts and bridge components) - Functional impressions - - Fabricating crown and bridgework or inlays - - -Fabricating full or partial dentures - Reline impressions - - -Use in the simultaneous mixing technique as well as the putty-wash and triple tray techniques - -Transferring root posts when fabricating posts and cores indirectly HySil Light Super Fast 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 - X Prescription Use (21 CFR 801 Subpart D) Over-The Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH. Office of Device Evaluation (ODE) {3}------------------------------------------------ ### Osstem Implant Co., Ltd. 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com ### 510(k) Summary ### Date: January 29, 2020 ### 1. Company and Correspondent making the submission | - | Submitter's Name | : Osstem Implant Co., Ltd. | |---|----------------------|---------------------------------------------------------------------------------| | - | Address | : 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan<br>48002, Republic of Korea | | - | Contact | : Ms. Jungmin Yoo | | - | Phone | : +82-51-850-2500 | | - | Correspondent's Name | : Hiossen Inc. | | - | Address | : 85 Ben Fairless Dr. Fairless Hills, PA 19030 | | - | Contact | : Mr. Peter Lee | | - | Phone | : +1-267-759-7031 | ### 2. Proposed Device | Trade or (Proprietary) Name | : | HySil Super Fast Impression Materials | |-----------------------------|---|---------------------------------------| | Classification Name | : | Impression Material | | Regulation Number | : | 21CFR872.3660 | | Devce Classification | : | Class II | | Classification Product Code | : | ELW | ### 3. Predicated Device - -Primary Predicate HySil Impression Materials, Osstem Implant Co., Ltd. (K170736) ### 4. Description HySil Super Fast Impression Materials are addition-curing, elastomeric materials with hydrophilic property. They are intended to be placed on an impression tray (or injected directly into the mouth, depending on the technique and device) and used to reproduce the structure of a patient's teeth and gums. HySil Super Fast Impression Materials meet ISO 4823 standard and consist of three different viscosities (heavy-bodied, medium-bodied, and light-bodied) in delivery system as standard 1:1 50 ml cartridges. {4}------------------------------------------------ Image /page/4/Picture/2 description: The image contains the logo for Osstem Implant. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. There is a small superscript "6" next to the word "OSSTEM". ## osstem® Osstem Implant Co., Ltd. 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com ### 5. Substantial Equivalence Matrix | | Proposed Devices | Predicated Devices | Remark | |----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | HySil Super Fast<br>Impression Materials<br>Heavy, Mono, Light | HySil Impression Materials<br>Putty, Heavy, Mono, Light,<br>Extra Light, Bite | Different | | 510(k) No. | K192941 | K170736 | Different | | Manufacturer | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Same | | Indications for<br>Use | HySil Heavy Super Fast is<br>to be used as heavy-bodied<br>materials for:<br>- One-step impression<br>technique (simultaneous<br>technique) using single or<br>dual viscosities<br>- Two-step impression<br>technique using dual<br>viscosities<br>- Functional impressions<br><br>HySil Mono Super Fast is<br>to be used as a medium-<br>bodied tray or syringeable<br>impression material for:<br>- Taking impressions over<br>fixed/removable<br>restorations and implants<br>(i.e., transferring<br>impression posts and<br>bridge components)<br>- Functional impressions<br>- Fabricating crown and<br>bridgework or inlays<br>- Fabricating full or partial<br>dentures<br>- Reline impressions<br>- Use in the simultaneous<br>mixing technique as well<br>as the putty-wash and<br>triple tray techniques<br>- Transferring root posts<br>when fabricating posts and<br>cores indirectly<br><br>HySil Light Super Fast is to<br>be used as syringeable<br>impression materials for:<br>- Two-step putty-wash<br>impression technique | HySil Putty is to be used as<br>preliminary materials for:<br>- Two-step Putty-wash<br>impression technique<br>- One-step Putty-wash<br>impression technique<br><br>HySil Heavy is to be used as<br>heavy-bodied materials for:<br>- One-step impression<br>technique (simultaneous<br>technique) using single or<br>dual viscosities<br>- Two-step impression<br>technique using dual<br>viscosities<br>- Functional impressions<br><br>HySil Mono is to be used as<br>a medium-bodied tray or<br>syringeable impression<br>material for:<br>- Taking impressions over<br>fixed/removable<br>restorations and implants<br>(i.e., transferring<br>impression posts and<br>bridge components)<br>- Functional impressions<br>- Fabricating crown and<br>bridgework or inlays<br>- Fabricating full or partial<br>dentures<br>- Reline impressions<br>- Use in the simultaneous<br>mixing technique as well<br>as the putty-wash and triple<br>tray techniques<br>- Transferring root posts<br>when fabricating posts and<br>cores indirectly | Different since<br>the predicated<br>devices have 6<br>types of devices,<br>Putty, Heavy,<br>Mono, Light,<br>Extra Light, and<br>Bite while the<br>proposed devices<br>have 3 types of<br>devices including<br>Heavy, Mono,<br>and Light.<br><br>Although there<br>are differences in<br>number of types,<br>the Indications<br>for Use<br>Statements of<br>Heavy, Mono and<br>Light type for<br>both proposed<br>and predicated<br>devices are same. | | | | | | | | - One-step putty-wash<br>impression technique<br>- Two-step impression<br>technique using dual<br>viscosities<br>- Reline impressions<br>- Fabricating full or partial<br>dentures | HySil Light is to be used as<br>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<br>technique using dual<br>viscosities<br>- Reline impressions<br>- Fabricating full or partial<br>dentures<br><br>HySil Extra Light is to be<br>used as syringeable<br>impression materials for:<br>- Two-step putty-wash<br>impression technique<br>- One-step putty-wash<br>impression technique<br>- Two-step impression<br>technique using dual<br>viscosities<br>- Reline impressions<br>- Fabricating full or partial<br>dentures<br><br>HySil Bite is used for<br>impression as below.<br>- Taking occlusal surfaces<br>- Confirming occlusal<br>surfaces<br>- Recording after putting the<br>articulator | | | Principle of<br>Operation | - Be placed on an<br>impression tray (or<br>injected directly into the<br>mouth, depending on the<br>technique and device) and<br>used to reproduce the<br>structure of a patient's<br>teeth and gums<br>- Provide models for study<br>and for production of<br>restorative prosthetic<br>devices | - Be placed on an<br>impression tray (or<br>injected directly into the<br>mouth, depending on the<br>technique and device) and<br>used to reproduce the<br>structure of a patient's<br>teeth and gums<br>- Provide models for study<br>and for production of<br>restorative prosthetic<br>devices | Same | | Description of<br>Material | Vinylpolysiloxane | Vinylpolysiloxane | Compose with<br>same affiliated<br>material, but<br>ratios of each | | | | | component in use<br>are different | | Standard<br>Conformed | ISO 4823 | ISO 4823 | Same | | Working Time | Over 1 min. 15 sec. | Over 2 ~ 2 min. 30 sec. | Proposed devices<br>have shorter<br>working time | | Shelf-life | 2 years | 2 years | Same | | S.E. | Similarities<br>The proposed devices and the predicated devices are made with same affiliated<br>material called Vinylpolysiloxane conformed to ISO 4823 standard. Both are<br>delivered in 50 ml catridge with base and catalyst ratio of 1 to 1; have same<br>indications for use; have same principle of operation; and have same shelf-life.<br>Differences<br>Compared to the predicated devices, the proposed devices have different<br>composition ratios which results in shorter working time. However, based on the<br>results of the performance and the biocompatibility testing, the proposed and the<br>predicated devices both passed the requirements. Also, there are differences in<br>Indications for Use Statement since the predicated devices have 6 types of<br>devices, Putty, Heavy, Mono, Light, Extra Light, and Bite while the proposed<br>devices have 3 types of devices including Heavy, Mono, and Light. Although<br>there are differences in number of types, the Indications for Use Statements of<br>Heavy, Mono and Light type for both proposed and predicated devices are same.<br>Thus, the differences in Indications for Use Statement do not affect the substantial<br>equivalence of proposed devices.<br>Therefore, we stated that proposed devices (HySil Heavy, Mono, Light Super<br>Fast Impression Materials) are substantially equivalent to the predicated devices<br>(HySil Heavy, Mono, Light Impression Materials) cleared in K170736. | | | {5}------------------------------------------------ IMPLANT ### osstem® Osstem Implant Co., Ltd. 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com {6}------------------------------------------------ ### Osstem Implant Co., Ltd. 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com ### 6. Indications for Use HySil Heavy Super Fast is to be used as heavy-bodied materials for: - One-step impression technique (simultaneous technique) using single or dual viscosities - Two-step impression technique using dual viscosities - Functional impressions HySil Mono Super Fast is to be used as a medium-bodied tray or syringeable impression material for: - Taking impressions over fixed/removable restorations and implants (i.e., transferring impression posts and bridge components) - Functional impressions - Fabricating crown and bridgework or inlays - Fabricating full or partial dentures - Reline impressions {7}------------------------------------------------ Image /page/7/Figure/2 description: This image shows the logo and contact information for Osstem Implant Co., Ltd. The logo includes the company name in bold, black font, with the word "OSSTEM" in orange font on the left side. The address is listed as 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea. The telephone number is +82 51 850 2500, the fax number is +82 51 861 4693, and the website is www.osstem.com. - Use in the simultaneous mixing technique as well as the putty-wash and triple tray techniques - Transferring root posts when fabricating posts and cores indirectly HySil Light Super Fast 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 ### 7. Summary of Non-clinical Performance Testing Non-clinical testing data are submitted to demonstrate substantial equivalence. #### Biocompatibility Evaluation Biocompatibility testing was considered followed the FDA Guidance Document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, " and the ISO 10993 suite of standards. #### Sterilization Validation and Shelf-life Proposed devices are delivered in non-sterile. Therefore, sterilization vas not considered. The Shelf-life testing was considered followed the FDA Guidance Document Shelf Life of Medical Device, ISO 4823 and ISO 3417; and determined shelf-life of proposed devices are 2 years. #### Mechanical Properties Mechanical testing was evaluated following ISO 4823, and it was found that the proposed devices are substantially equivalent to the predicate devices from the result of bench test. ### 8. Summary of Clnical Testing No clinical studies are submitted. ### 9. Conclusion In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification, Osstem Implant Co., Ltd. concludes that the HySil Super Fast Impression Materials are substantially equivalent to the predicated devices as herein. {8}------------------------------------------------ Image /page/8/Picture/2 description: The image shows the logo for Osstem Implant. The logo is orange and gray. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. There is a small superscript "6" next to the word "OSSTEM". # osstem® Osstem Implant Co., Ltd. Complant 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com