Amber Mill Q Series & Amber Mill Direct Series

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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 logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. August 26, 2021 HASS Corp. % Priscilla Chung Regulatory Affairs Consultant Lk Consulting Group USA, Inc. 1150 Roosevelt STE 200 Irvine, California 92620 Re: K202952 Trade/Device Name: Amber Mill Q Series & Amber Mill Direct Series Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: May 19, 2021 Received: May 28, 2021 Dear Priscilla Chung: 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 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) K202952 Device Name Amber Mill Q Series & Amber Mill Direct Series Indications for Use (Describe) Once finalized into a suitable design, the Amber Mill O Series and Amber Mill Direct Series are indicated for use as inlays, onlays, veneer, partial crowns and crowns. 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 (K202952) This summary of 510(K) information is being submitted in accordance with requirements of 21 CFR Part 807.92. Date: 8/9/2021 ## 1. Submitter HASS CORP. 77-14. Gwahakdanji-ro Gangneung-si, Gangwon-do, Republic of Korea, 25452 Tel: +82-70-7712-1300 Fax: +82-33-644-1231 ## 2. U.S Agent/Contact Person Priscilla Chung LK Consulting Group USA, Inc. 1150 Roosevelt STE 200, Irvine CA 92620 Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c(@lkconsultinggroup.com ## 3. Device - . Trade Name: Amber Mill Q Series & Amber Mill Direct Series - Common Name: Dental Frame Material for Dental Prosthesis - Classification Name: Porcelain Powder for Clinical Use ● - Product Code: EIH - . Classification regulation: 21 CFR 872.6660 ## 4. Primary Predicate Device: Straumann n!ce Glass-Ceramic Blocks by Institut Straumann AG (K160262) ## 5. Description: Amber Mill Q Series and Amber Mill Direct Series are a lithium disilicate ceramic to be supplied in the form of Blocks. Amber Mill O Series & Amber Mill Direct Series can be fabricated using CAD/CAM technologies. The subject devices are intended to be milled to produce prosthetic restorations for natural and endosseous dental implant abutment borne {4}------------------------------------------------ teeth. The subject devices are glass type material used for aesthetic purposes of veneers, inlays, onlays, single-unit anterior and posterior crowns. The ceramics material is composed of SiO2, Li2O, K2O, P2O5, A12O3 and other oxides. It also contains inorganic pigments to provide different shades on the product surface. The subject device offers 18 different size/shape series and each series offers 45 different shades. 18 different sizes are to be used with various equipment for CAD/CAM milling and to meet the needs of patients' various tooth shapes. 45 different shades are offered to meet the needs of different patient's tooth colors. The subject devices don't need sintering since they are provided fully crystallized. The only difference between Amber Mill Q Series and Amber Mill Direct Series is that the Amber Mill Q series has a hole in the center combined with a zirconia cap. The holes in Amber Mill Q are sizes compatible with abutment, through which are bonded to abutment to be connected to the implant. The CAD/CAM systems and abutments compatible with Amber Mill Q series are as follows : | CAD/CAM System: | Sirona Dental CAD/CAM system (K193408) | |-----------------|----------------------------------------| | Abutment: | Sirona TiBase (K193408) | {5}------------------------------------------------ #### 6. Indication for use: Once finalized into a suitable design, the Amber Mill Q Series and Amber Mill Direct Series are indicated for use as inlays, onlays, veneer, partial crowns and crowns. #### 7. Basis for Substantial Equivalence Amber Mill Q Series and Amber Mill Direct Series are substantially equivalent to the Straumann n!ce Glass-Ceramic (K160262) The following comparison table is presented to demonstrate substantial equivalence. | | Proposed Device | Primary Predicate Device | Comparison Discussion | |--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K202952 | K160262 | Equivalent | | Device Name | Amber Mill Q Series and<br>Amber Mill Direct Series | Straumann n!ce Glass-Ceramic<br>Blocks | - | | Common Name | Porcelain powder for clinical<br>use | Porcelain powder for clinical<br>use | - | | Manufacturer | HASS CORP. | Institut Straumann AG | - | | Indication For Use | Once finalized into a suitable<br>design, the Amber Mill Q<br>Series and Amber Mill Direct<br>Series are indicated for use as<br>inlays, onlays, veneer, partial<br>crowns and crowns. | Once finalized into a suitable<br>design, the n!ceTM glass-<br>ceramic blocks are indicated<br>for use as inlays, onlays,<br>veneer, partial crowns and<br>crowns. | Equivalent | | Classification Reg | 21 CFR 872.6660 | 21 CFR 872.6660 | Identical | | FDA Product Code | EIH | EIH | Identical | | Materials | SiO2, Li2O, K2O,<br>P2O5, Al2O3 and other<br>oxides | SiO2, Li2O, K2O,<br>P2O5, Al2O3 and other oxides | Equivalent | | Crystallization<br>State as Supplied | Fully crystallized | Fully crystallized | Equivalent | | Device Design | Block | Block | Equivalent | | Size | C12 block(10 x 12 x 15mm)<br>C14 block(12 x 14 x 18mm)<br>C16 block(17.5 x 16 x<br>18mm) | C14 block(12.4 x14.5<br>x18.0mm) | (Similar)#1<br>* Proposed device and<br>predicate device are essentially | | | | | equivalent, but the proposed<br>device has various size of<br>models. | | Shades | Various<br>Translucency :<br>High translucency(HT)<br>Low translucency(LT)<br>Medium Opacity(MO)<br>Shade :<br>LT/ HT : 16 A-D and 4<br>Bleach<br>MO : 5 MO0- MO4 | Various<br>Translucency :<br>High translucency(HT)<br>Low translucency(LT)<br>Shade :<br>HT/ LT : 6 A-D | Equivalent | | Principle of<br>Operation | Fabricating restorations<br>using CAD/CAM system | Fabricating restorations using<br>CAD/CAM system | Equivalent | | Type/Class per<br>ISO 6872 | Type Ⅱ, Class 3 | Type Ⅱ, Class 2 | (Similar)#2<br>* Proposed devices and<br>predicate devices are<br>essentially equivalent, but the<br>indication vary depending on<br>the classification of clinical use<br>in ISO 6872.<br>Classification is determined by<br>mechanical and chemical<br>properties.<br>The result of flexural strength<br>tested according to ISO 6872<br>standard is 519 MPa, so it<br>corresponds to Class 3<br>according to Table 1.<br>Classification table. | | Flexural strength | > 300MPa<br>(meeting the ISO6872<br>requirements) | > 100MPa<br>(meeting the ISO6872<br>requirements) | Equivalent | | Chemical solubility | < 100 ug / cm $^{2}$<br>(meeting the ISO6872<br>requirements) | < 100 ug / cm $^{2}$<br>(meeting the ISO6872<br>requirements) | Equivalent | | Freedom from<br>Extraneous Material | Shall be free from extraneous<br>materials when assessed by<br>visual inspection ( meeting<br>ISO 6872 requirements) | Shall be free from extraneous<br>materials when assessed by<br>visual inspection ( meeting<br>ISO 6872 requirements) | Equivalent | | Radioactivity | Activity<br>concentration of<br>uranium $^{238}$ less<br>than 1.0Bq g $^{-1}$<br>(meeting the ISO6872<br>requirements) | Activity<br>concentration of<br>uranium $^{238}$ less<br>than 1.0Bq g $^{-1}$<br>(meeting the ISO6872<br>requirements) | Identical | | Linear of thermal<br>expansion | 11.5±0.5 × 10 $^{-6}$ /°C<br>(meeting the ISO6872<br>requirements) | 12.0±0.5 × 10 $^{-6}$ /°C<br>(meeting the ISO6872<br>requirements) | Equivalent | | Glass Transition<br>Temperature | Activity<br>concentration of<br>uranium $^{238}$ less | Activity<br>concentration of<br>uranium $^{238}$ less | Equivalent | | | than 1.0Bq g-1<br>(meeting ISO 6872<br>requirements) | than 1.0Bq g-1<br>(meeting ISO 6872<br>requirements) | | | Biocompatibility | Non-toxic and biocompatible<br>(Meeting the ISO<br>10993-3, 5, 10 and<br>10993-11<br>Requirements) | Non-toxic and biocompatible<br>(Meeting the ISO<br>10993-5 and<br>10993-10<br>Requirements) | Equivalent | 510(k) summary {6}------------------------------------------------ {7}------------------------------------------------ Substantial Equivalence Discussion The subject device has the same intended use and the same principle of operation as the predicate devices. The subject device and the predicate devices might have a slight difference in compositions but all the devices have SiO2, Li2O, K2O, P2O5, and A12O3 as major components. Despite this difference, the test results per ISO 6872 shows that the subject device is substantially equivalent to the predicate device in physical and chemical properties and meets the necessary requirements. In addition, the subject device has been tested for Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), and Irritation (ISO 10993-10) to meet the biocompatibility requirements. Based on the test results and the information provided in this submission, we conclude that the subject device is substantially equipment to the predicate devices. ## 8. Non-Clinical Testing - . Performance Tests including Flexural strength, Chemical solubility, Freedom from Extraneous Material, Radioactivity, Linear of thermal expansion, Glass Transition Temperature in accordance with ISO 6872 - Biocompatibility tests in accordance with ISO 10993-5, 10, and 11. ● ## 9. Conclusion The subject device and the predicate device have the same intended use and have the same technological characteristics. Based on the similarities and the test results, we conclude that the subject device is substantially equivalent to the predicate device.