← Product Code [EIH](/productcode/EIH) · K201492 # Non-Sterile Zirconia Block (K201492) _Bioden Co., Ltd. · EIH · Mar 10, 2021 · Dental · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K201492 ## Device Facts - **Applicant:** Bioden Co., Ltd. - **Product Code:** [EIH](/productcode/EIH.md) - **Decision Date:** Mar 10, 2021 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.6660 - **Device Class:** Class 2 - **Review Panel:** Dental ## Indications for Use Non-Sterile Zirconia Block (Model: Zircos-E ACE) is indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers. ## Device Story Zircos-E ACE is a zirconia block used as a raw material for dental restorations. It is processed by dental professionals using CAD/CAM systems to cut and shape the material, followed by sintering to produce final dental prosthetics such as crowns, veneers, and dentures. The device is intended for permanent contact with the oral environment. It benefits patients by providing a durable, biocompatible material for tooth replacement or restoration. The device is supplied non-sterile and is intended for prescription use in a clinical or laboratory setting. ## Clinical Evidence No clinical data. Bench testing only, including density testing and biocompatibility assessments (cytotoxicity per ISO 10993-5, intracutaneous reactivity and sensitization per ISO 10993-10, acute systemic toxicity per ISO 10993-11) and performance testing per ISO 6872. ## Technological Characteristics Material: Zirconia (ZrO2); Type II Class 5 ceramic per ISO 6872:2015. Form factor: Discs. Sintering temperature: 1500±50°C. Density: 6.00g/cm3. Crystal morphology: Tetragonal. Non-sterile. Intended for CAD/CAM processing. ## Regulatory Identification Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish. ## Predicate Devices - Finebase, Montblanc, Trione HT, Trione C, Trione HT+ ([K190112](/device/K190112.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo features a stylized human figure, while the FDA part includes the acronym "FDA" in a blue square, followed by "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text. March 10, 2021 Bioden Co., Ltd % Chris Park General Manager Med.com 1809 Holland dr Somerset, New Jersey 08873 Re: K201492 Trade/Device Name: Non-Sterile Zirconia Block Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: Class II Product Code: EIH Dated: December 3, 2020 Received: December 10, 2020 Dear Chris Park: 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 {1}------------------------------------------------ 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 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 (QS) 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 medical devices and radiation-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) K201492 Device Name Non-Sterile Zirconia Block Model: name: Zircos-E ACE Indications for Use (Describe) Non-Sterile Zirconia Block (Model: Zircos-E ACE) is indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers. 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}------------------------------------------------ # 510(k) Summary This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92 The assigned 510(k) Number: K201492 - 1. Date of Preparation: Mar/09/2021 - 2. Sponsor Identification BIODEN Co.,Ltd Address: #B-803 119, Gasan digital 1-ro, Geumcheon-gu, Korea Establishment Registration Number: Not yet registered for the Number Contact Person: MyeongEun Song Position: QA Tel: +82-2-6292-2840 Fax: 82-2-6292-2846 Email: < bio0790@daum.net> - 3. Identification of Proposed Device Trade Name: Non-Sterile Zirconia Block Common Name: Zirconia Blocks Regulatory Information Classification Name: Porcelain powder for clinical use Classification: 2 Product Code: EIH Regulation Number: 872.6660 Review Panel: Dental Indications for Use Statemen: Non-Sterile Zirconia Block (Model name: Zircos-E ACE) is indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers. Device Description Non-Sterile Zirconia Block (Model name: Zircos-E ACE) is a manufacture unit that is cut, processed and sintered by CAD/CAM system of the computers designed for production of dental restoration. - 4. Identification of Predicate Device(s) Primary predicate - 510(k) number: K190112 - Company: FINE ADVANCED COMPOUND Co., Ltd - Model: Finebase, Montblanc, Trione HT, Trione C, Trione HT+ - Classification: Class II {4}------------------------------------------------ - Non-Clinical Test Conclusion ર. Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device, including - Performance Test per ISO 6872 Fourth Edition 2015-06-01, Dentistry Ceramic Materials. > - > Density Test - > Cytotoxicity per ISO 10993-5:2009; - > Intracutaneous Reactivity Test per ISO 10993-10:2010; - > Sensitization Test per ISO 10993-10:2010 - > Acute Systematic Toxicity per ISO 10993-11:2006; - 6. Clinical Test Conclusion No clinical study is included in this submission. - 7. Substantially Equivalent (SE) Comparison {5}------------------------------------------------ ### 510(k) Summary | Table 1 Comparison of Technology Characteristics | | | | |--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------| | ITEM | Non-Sterile Zirconia Block
(Model name: Zircos-E ACE) | Non-Sterile Zirconia Block
(Model name: Finebase, Montblanc, Trione HT, Trione C, Trione HT+) | Model names various | | Product Code | EIH | EIH | Equivalen | | Regulation Number | 872.6660 | 872.6660 | Equivalence | | Indication for use | Non-Sterile Zirconia Block
(Model name: Zircos-E ACE) are indicated for the
production of artificial teeth in fixed or removable
dentures, or for jacket crowns, facings, and veneers. | Non-Sterile Zirconia Block
(Model name: Finebase, Montblanc, Trione HT, Trione C, Trione HT+) are indicated for the
production of artificial teeth in fixed or removable dentures,
or for jacket crowns, facings, and veneers. | Indication for use is equal | | Feature | Colored | Colored | Equivalencel | | Shape | Discs | Discs | Equivalence | | Type and Class
per ISO 6872:
2015 | Type II Class 5 | Type II Class 5 | Equivalence | | Sterility | Non-sterile | Non-sterile | Equivalence | | Chemical
Composition | ZrO2 with others | ZrO2 with others | Equivalencel | | Crystal
Morphology | Tetragonal | Tetragonal | Equivalence | | Density | 6.00g/cm3 | 6.00g/cm3 | Equivalence | | Sintering
temperature | $1500\pm50°C$ | $1500\pm50°C$ | Equivalence | | Performance | Comply with ISO 6872 | Comply with ISO 6872 | Equivalence | | Contact Level | surface device with permanent
contact | surface device with permanent
contact | Equivalence | | Biocompatibility | Tested for Cytotoxicity,
irritation, sensitization,
accurate systematic toxicity,
genotoxicity, no adverse react | Tested for Cytotoxicity,
irritation, sensitization, accurate
systematic toxicity, genotoxicity,
no adverse react | Equivalence | {6}------------------------------------------------ Subject device, Based on the table above, the intended use of Zircos-E ACE is identical to the other equivalent devices and there is no significant clinical difference in the performance and stability when comparing the technical characteristics and biological natures. ### Substantially Equivalent (SE) Conclusion Based on the comparison and analysis above, the proposed devices Non-Sterile Zirconia Block (Model name: Zircos-E ACE) is determined to be Substantially Equivalent (SE) to the predicate devices K190112/ Company: FINE ADVANCED COMPOUND Co., Ltd/ Model: Finebase, Montblanc, Trione HT, Trione C, Trione HT+. --- **Source:** [https://fda-staging.innolitics.com/device/K201492](https://fda-staging.innolitics.com/device/K201492) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com