Estar-Z

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July 2, 2021 Osstem Implant Co., Ltd. % Peter Lee RA/QA Manager Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030 Re: K210097 Trade/Device Name: Estar-Z Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: June 3, 2021 Received: June 4, 2021 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, Michael E. Adjodha, M.ChE. 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K210097 Device Name Estar-Z Indications for Use (Describe) Estar-Z is a ceramic intended to manufacture dental restorations, including inlays, artificial teeth, crowns and bridges. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Company and Correspondent making the submission | - Submitter's Name | : Osstem Implant Co., Ltd. | |------------------------|----------------------------------------------------------------------------------------| | - Address | : A-dong, 51, Mayu-ro 238beon-gil, Siheung-Si<br>Gyeonggi-do, 15079, Republic of Korea | | - Contact | : Ms. Jungmin Yoo | | - Phone | : +82-70-4394-7896 | | - 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 | : Estar-Z | |-------------------------------|-------------------------------------| | - Classification Name | : Porcelain powder for clinical use | | - Regulation Number | : 21 CFR 872.6660 | | - Devce Classification | : Class II | | - Classification Product Code | : EIH | #### 3. Predicated Device(s) - Primary Predicate -LUXEN Zr, LUXEN Smile, DENTALMAX Co., Ltd. (K171785) #### 4. Description Estar-Z is a ceramic intended to manufacture dental restorations, including inlays, artificial teeth, crowns and bridges. Estar-Z is prefabricated ceramic block (pre-sintered yttrium-stabilized zirconium oxide) which is to be milled and sintered in the furnace to produce the final dental restorations. After sintering, it forms polycrytstalline oxide ceramic consisted of Tetragonal Zirconium Oxide Polycrystal (TZP). {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo and contact information for Osstem Implant Co., Ltd. The logo includes the company name and the word "IMPLANT" in smaller letters. The contact information includes the company's address, phone number (+82 70 4394 7896), fax number (+82 31 498 0824), and website (www.osstem.com). Estar-Z is provided in three types as Estar-Z T, Estar-Z HT, and Estar-Z ST. In accordance with ISO 6872:2015, Estar-Z T and Estar-Z HT are classified as Type II Class 5 zirconia and Estar-Z ST is classified as Type II Class 4b zirconia. Estar-Z is provided in non-sterile and available in various shades and thickness of disk shape (Ø98mm) as follows: | Estar-Z T | | |----------------|--------------------------------------------------------------| | Shade | A0, A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, D2, D3, D4 | | Thickness (mm) | 10, 12, 14, 16, 18, 20, 22, 25 | | Estar-Z HT | | |--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Shade | A0, A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4, Z4<br>Multi A1, Multi A2, Multi A3, Multi A3.5, Multi A4, Multi B1, Multi B2,<br>Multi B3, Multi B4, Multi C1, Multi C2, Multi C3, Multi C4, Multi D2, Multi D3, Multi D4 | | *Shade with 'Multi': Multi-layered zirconia has color gradation similar to the color of natural teeth. | | | Thickness (mm) | 10, 12, 14, 16, 18, 20, 22, 25 | | Estar-Z ST | | | | | | |----------------|--------------------------------------------------------------|--|--|--|--| | Shade | A0, A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, D2, D3, D4 | | | | | | Thickness (mm) | 10, 12, 14, 16, 18, 20, 22, 25 | | | | | ## 5. Substantial Equivalent Comparison | | Proposed Device | Predicate Device | Comparison | |----------------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Device Name | Estar-Z T<br>Estar-Z HT | LUXEN Zr | Different | | 510(k) Number | K210097 | K171585 | Different | | Manufacturer | Osstem Implant Co., Ltd. | DENTALMAX Co., Ltd. | Different | | Regulation Name | Porcelain powder for clinical use | Porcelain powder for clinical use | Same | | Regulation Number | 872.6660 | 872.6660 | Same | | Product Code | EIH | EIH | Same | | Device Class | II | II | Same | | Indications for Use | Estar-Z is a ceramic intended to<br>manufacture dental restorations,<br>including inlays, artificial teeth,<br>crowns and bridges. | LUXEN Zr is indicated for the<br>production of all-ceramic inlays,<br>multi-units bridges, onlays, and<br>veneers without zirconium dioxide<br>frameworks. | Similar | | Principle of<br>Operations | This partial sintered zirconia block is<br>milled and finally sintered to make<br>dental prosthesis. | This partial sintered zirconia block is<br>milled and finally sintered to make<br>dental prosthesis. | Same | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font. To the right of the word "OSSTEM" is a small, raised circle, which is a trademark symbol. Osstem Implant Co., Ltd. A-dong, 51, Mayu-ro 238beon-gil, Siheung-si, Gyeonggi-do, Korea Tel: +82 70 4394 7896 Fax: +82 31 498 0824 www.osstem.com #### P | | Physical Properties | | | | |--|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|-----------| | | Standard<br>Conformed | ISO 6872:2015 | ISO 6872:2015 | Same | | | Classification | Type II Class 5 | Type II Class 5 | Same | | | Flexural<br>Strength | $>800 MPa$ | $1038 ± 135 MPa$ | Similar | | | Delivery<br>Form(s) | Disk type | Disk type | Same | | | Thickness | 10, 12, 14, 16, 18, 20, 22, 25mm | 10, 12, 14, 16, 18, 20, 22, 25mm | Same | | | Shade(s) | Estar-Z T:<br>A0, A1, A2, A3, A3.5, A4,<br>B1, B2, B3, B4,<br>C1, C2, D2, D3, D4<br><br>Estar-Z HT:<br>A0, A1, A2, A3, A3.5, A4,<br>B1, B2, B3, B4,<br>C1, C2, C3, C4,<br>D2, D3, D4, Z4,<br>Multi A1, Multi A2, Multi A3, Multi<br>A3.5, Multi A4, Multi B1, Multi B2,<br>Multi B3, Multi B4,<br>Multi C1, Multi C2, Multi C3, Multi<br>C4, Multi D2, Multi D3, Multi D4 | A0, A1, A2, A3,<br>B1, B2, B3, B4, C4,<br>B1-B2-B3-B4<br>LAYER | Different | | | Sterile | Non-sterile | Non-sterile | Same | | | Biocompatibility Evaluation | | | | | | Standard<br>Conformed | ISO 10993-1 and ISO 7405 | ISO 10993-1 | Similar | | | Classification | Externally communicating device in<br>oral mucosa, enamel, and dentin; | Externally communicating device in<br>oral mucosa, enamel, and dentin; | Same | T | | Proposed Device | Predicate Device | Comparison | |---------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Device Name | Estar-Z ST | LUXEN Smile | Different | | 510(k) Number | K210097 | K171585 | Different | | Manufacturer | Osstem Implant Co., Ltd. | DENTALMAX Co., Ltd. | Different | | Regulation Name | Porcelain powder for clinical use | Porcelain powder for clinical use | Same | | Regulation Number | 872.6660 | 872.6660 | Same | | Product Code | EIH | EIH | Same | | Device Class | II | II | Same | | Indications for Use | Estar-Z is a ceramic intended to<br>manufacture dental restorations,<br>including inlays, artificial teeth,<br>crowns and bridges. | LUXEN Zr is indicated for the<br>production of all-ceramic inlays,<br>multi-units bridges, onlays, and<br>veneers without zirconium dioxide<br>frameworks. | Similar | (>30d) and contact duration of C-long term and contact duration of C-long term (>30d) {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for Osstem Implant. The logo is in orange and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, thinner font. There is a degree symbol to the right of the word "OSSTEM". **Osstem Implant Co., Ltd.** A-dong, 51, Mayu-ro 238beon-gil, Siheung-si, Gyeonggi-do, Korea Tel: +82 70 4394 7896 Fax: +82 31 498 0824 www.osstem.com | Principle of<br>Operations | This partial sintered zirconia block is<br>milled and finally sintered to make<br>dental prosthesis. | This partial sintered zirconia block is<br>milled and finally sintered to make<br>dental prosthesis. | Same | |-----------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-----------| | Physical Properties | | | | | Standard<br>Conformed | ISO 6872:2015 | ISO 6872:2015 | Same | | Classification | Type II Class 4b | Type II Class 4b | Same | | Flexural<br>Strength | $>500$ MPa | $770 \pm 66$ MPa | Similar | | Delivery<br>Form(s) | Disk type | Disk type | Same | | Thickness | 10, 12, 14, 16, 18, 20, 22, 25mm | 10, 12, 14, 16, 18, 20, 22, 25mm | Same | | Shade(s) | A0, A1, A2, A3, A3.5, A4,<br>B1, B2, B3, B4,<br>C1, C2, D2, D3, D4 | A0, A1, A2, A3,<br>B1, B2, B3, B4, C4,<br>A1-A2-B3-B4 LAYER<br>B1-B2-B3-B4 LAYER | Different | | Sterile | Non-sterile | Non-sterile | Same | | Biocompatibility Evaluation | | | | | Standard<br>Conformed | ISO 10993-1 and ISO 7405 | ISO 10993-1 | Similar | | Classification | Externally communicating device in<br>oral mucosa, enamel, and dentin;<br>and contact duration of C-long term<br>(>30d) | Externally communicating device in<br>oral mucosa, enamel, and dentin;<br>and contact duration of C-long term<br>(>30d) | Same | ### 6. Indications for Use Estar-Z is a ceramic intended to manufacture dental restorations, including inlays, artificial teeth, crowns and bridges. - 7. Summary of Non-clinical Performance Testing Non-clinical testing data are submitted to demonstrate substantial equivalence following FDA recognized standards: - ISO 6872:2015, Dentistry Ceramic materials . - . ISO 7405:2018, Dentistry - Evaluation of biocompatibility of medical devices used in dentistry - . ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process - . ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity - . ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization - ISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, thinner font. To the right of the word "OSSTEM" is a small circle with a dot in the center, which is likely a registered trademark symbol. **Osstem Implant Co., Ltd.** A-dong, 51, Mayu-ro 238beon-gil, Siheung-si, Gyeonggi-do, Korea Tel: +82.70 4394 7896 Fax: +82 31 498.0824 www.osstem.com - ISO 10993-14:2001, Biological evaluation of medical devices Part 14: Identification and qualification of degradation products from ceramics - . ISO 13356:2015, Implants for surgery - Ceramic materials based on yttriastabilized tetragonal zirconia (Y-TZP) - ISO 14971:2007, Medical devices - Application of risk management to medical devices ## Biocompatibility Evaluation Biocompatibility evaluation of proposed Estar- Z 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," ISO 7405 and the ISO 10993 suite of standards. The biocompatibility for the proposed device was found to be substantially equivalent to the predicate devices as a result. ### Sterilization Validation and Shelf-life Proposed Estar-Z is delivered in non-sterile status and this device is unnecessary of sterilization prior to use. Therefore, sterilization was not considered. ### Mechanical Properties Proposed Estar-Z has been designed and tested in accordance with ISO 6872 Dentistry - Ceramic Materials and ISO 13356 Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP). All tests have passed the evaluation criteria and met the requirement of product-specific ISO 6872 specifies for Class 4b and Class 5 dental ceramics. The mechanical properties were found to be substantially equivalent to the predicate devices as a result. ### 8. Summary of Clinical Testing No clinical studies are submitted. ## 9. Conclusion The conclusions drawn from the nonclinical and clinical tests that demonstrate that Estar-Z is as safe, as effective, and performs as well as the legally marketed predicate device.