Pre-Sintered Zirconia Coloring Liquid

{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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. March 19, 2024 Chengdu Besmile Medical Technology Co., Ltd. Moushan Liu Quality Manager No.9, Sec.2, Shengwucheng North Rd., Chengdu Tianfu International Bio-Town, Shuangliu District Chengdu, Sichuan 610200 CHINA Re: K232682 Trade/Device Name: Pre-Sintered Zirconia Coloring Liquid Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: September 1, 2023 Received: December 20, 2023 Dear Moushan Liu: 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 (the 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 available 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. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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). {2}------------------------------------------------ Sincerely, # Michael E. Adjodha -S Michael E. Adjodha, MChE, RAC, CQIA 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 {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K232682 Device Name Pre-Sintered Zirconia Coloring Liquid Indications for Use (Describe) It is only used for coloring Zirconia Dental Ceramics of our company to achieve clinical aesthetic restoration. Type of Use (Select one or both, as applicable) | <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | |---------------------------------------------------------------------------------------------------------------------------------| | <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | 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." {4}------------------------------------------------ # Section 3 510(k) Summary #### l 510(k) Submitter | Device Submitter: | Chengdu Besmile Medical Technology Co., Ltd. | |-------------------|--------------------------------------------------------------| | | No.9,Sec.2, Shengwucheng North Rd., Chengdu Tianfu | | | International Bio-Town, Shuangliu District, Chengdu, Sichuan | | | 610200, P.R.China | | Contact Person: | Moushan Liu (Mr.) | | | Manager | | | Phone: 86-28-85317108 | | | E-mail: 79802494@qq.com | #### II Device | Trade Name of Device: | Pre-Sintered Zirconia Coloring Liquid | |-----------------------|---------------------------------------| | Regulation Number: | 21 CFR 872.6660 | | Classification Name: | Powder, Porcelain | | Product Code: | EIH | | Regulatory Class | II | | Review Panel | Dental | #### III Predicate Devices | 510k Number | K141723 (Primary predicate) | |-----------------------|-----------------------------------| | Trade Name of Device: | Upcera Coloring Liquid (I and II) | | Regulation Number: | 21 CFR 872.6660 | | Regulation Name: | Powder, Porcelain | | Regulatory Class | II | | Product Code: | EIH | #### IV Device Description Pre-Sintered Zirconia Coloring Liquid is mainly divided into 16 colors, 26 colors and special colors. The product is mainly composed of purified water(55%~95%), ferric chloride (0~9%), Erbium Chloride(0~17%), polyethylene glycol(2%~6%),Polydextrose(0.5%~8%),Gluconic acid(1%~2%),Citric acid(0%~1%) and Yttrium chloride(0~12%). #### V Indications for use It is only used for coloring Zirconia Dental Ceramics of our company to achieve clinical aesthetic restoration. #### VI Technological Characteristics Comparison {5}------------------------------------------------ | Device<br>Characteristic | Subject Device | Predicate Device<br>(K141723) | Discussion | |--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------| | Trade name | Pre-Sintered Zirconia Coloring<br>Liquid | Upcera Coloring Liquid (I and II) | N/A | | Product code | EIH | EIH | Identical | | Regulation<br>Number | 21 CFR 872.6660 | 21 CFR 872.6660 | Identical | | Regulatory<br>class | Class II | Class II | Identical | | Manufacturer | Chengdu Besmile Medical<br>Technology Co., Ltd. | Liaoning Upcera Co., Ltd. | N/A | | Intended Use | It is only used for coloring<br>Zirconia Dental Ceramics of our<br>company to achieve clinical<br>aesthetic restoration. | Upcera Coloring Liquid (I and II)<br>is a liquid used for the complete<br>or partial coloration of milled<br>Upcera zirconia substructure and<br>anatomy before sintering. | Similar<br>Comment1 | | Structure<br>Composition | The product is mainly composed<br>of purified water(55%~95%),<br>ferric chloride (0~9%), Erbium<br>Chloride(0~17%), polyethylene<br>glycol(2%~6%),<br>Polydextrose(0.5%~8%),Gluconi<br>c acid(1%~2%),Citric<br>acid(0%~1%) and Yttrium<br>chloride(0~12%). | Water, polyethylene glycol, HCI,<br>inorganic salts. | Similar<br>Comment 2 | | Physical Form | Liquid | Liquid | Identical | | Operation<br>Principle | Immersion method:<br>1) Shake the coloring liquid well<br>before dyeing. Choose the<br>appropriate container and pour in<br>the appropriate amount of<br>coloring liquid.<br>2) Zirconia was lightly put into<br>coloring liquid with plastic<br>tweezers and soaked for 10<br>seconds. | Brush or immerse zirconia dental<br>ceramics with coloring liquid<br>before sintering. | Similar<br>Comment3 | | Device<br>Characteristic | Subject Device | Predicate Device<br>(K141723) | Discussion | | | 30-60 minutes (it is | | | | | recommended to use infrared | | | | | lamp or oven and place it in the | | | | | position of 8-100mm under | | | | | infrared lamp or at 80-90 °C of | | | | | oven). | | | | | 4) The dyed zirconia was | | | | | compared with VITA*16 color | | | | | system, VITA*26 color system | | | | | and Special colors (01, 02, 03, | | | | | G1, G2, G3, P1, P2, P3, V1, V2, | | | | | V3, TO1, TO2, TO3, TO4, BL1, | | | | | BL2,BL3, BL4, 0M1, 0M2,0M3). | | | | | Brushing method: | | | | | 1) Shake the coloring liquid well | | | | | before dyeing. Choose the | | | | | appropriate container and pour in | | | | | the appropriate amount of | | | | | coloring liquid. | | | | | 2) Zirconia was dipped in coloring | | | | | liquid with a ceramic pen and | | | | | brushed 1-2 times. | | | | | 3) Zirconia is dried for 30-60 | | | | | minutes (it is recommended to | | | | | use infrared lamp or oven and | | | | | place it in the position of | | | | | 8-100mm under infrared lamp or | | | | | at the temperature of 80-90 °C in | | | | | the oven). | | | | | 4) The dyed zirconia was | | | | | compared with VITA*16 color | | | | | system, VITA*26 color system | | | | | and Special colors (01, 02, 03, | | | | | G1, G2, G3, P1, P2, P3, V1, V2, | | | | | V3, TO1, TO2, TO3, TO4, BL1, | | | | | BL2,BL3, BL4, 0M1, 0M2,0M3). | | | | Device<br>Characteristic | Subject Device | Predicate Device<br>(K141723) | Discussion | | | BL2, BL3, BL4, 0M1, 0M2, 0M3). | | | | Bottle Size | Various | Various | Identical | | Type of<br>Packaging | Liquid container | Liquid container | Identical | | Color | Various | Various | Identical | | Prescription<br>Use | Prescription only | Prescription only | Identical | | Sterility | Non-sterile | Non-sterile | Identical | VI-1: Comparison of Pre-Sintered Zirconia Coloring Liquid {6}------------------------------------------------ {7}------------------------------------------------ #### Comment 1 The Indications for Use of the two are only different in the description of the text, and the actual intended use is the same, which does not affect the safety and effectiveness of the product.And both have exactly the same intended use: as a zirconia dental ceramic colorant. #### Comment 2 There are some minor differences between Pre-Sintered Zirconia Coloring Liquid and the predicate device. First, the predicate device contains HCI. HCI will be evaporated with no residue left at the sintering step after the coloring liquid is applied to the zirconia dental ceramics, so it will not cause any effect to the patients. Second, Pre-Sintered Zirconia Coloring Liquid and the predicate device both use inorganic pigments(Ferric chloride and erbium chloride belong to inorganic salts). This does not raise any safety concerns as the product is tested for biocompatibility. The inorganic pigments we use also have long established safety profiles. #### Comment 3 The understanding of the product varies between manufacturers, and the Subject Device describes the working principle in more detail. ### VII Summary of Non-clinical Testing (Bench) The non-clinical testing for Pre-Sintered Zirconia Coloring Liquid was performed to demonstrate verification testing in conformance with the acceptance criteria of test methods and recognized consensus standards shown below. | ID# | Test | Method | Acceptance Criteria | Conclusion | |-----|-----------------------------------------------------------|----------------------------|---------------------|------------| | 1 | Physical Testing of Pre-Sintered Zirconia Coloring Liquid | | | | | 1.1 | Specification | Specification deviation of | Product technical | Pass | #### ducted on the subject devic Toblo VII 1: Porformance tocting was co {8}------------------------------------------------ | | | requirements | | requirements | | |-----|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|--------------|------| | 1.2 | Appearance | coloring liquid should be (±2 ml).<br>The coloring liquid should be homogeneous and impurity-free liquid. | | | Pass | | 1.3 | Post-dyeing comparison requirements | After dyeing, there was no significant difference in color between dental specimens and VITA veneer colorimeter or standard dental specimens. | | | Pass | | 1.4 | Heavy metal content | Heavy metal content (in Pb) less than 10 mg/L. | | | Pass | | 2 | Biocompatibility Testing | | | | | | 2.1 | Cytotoxicity | ISO 10993-5:2009 | Non-cytotoxic | | Pass | | 2.2 | Delayed hypersensitivity | ISO 10993-10:2010 | Non-Delayed hypersensitivity | | Pass | | 2.3 | Intradermal reaction | ISO 10993-10:2010 | Non-Intradermal reaction | | Pass | | 2.4 | Acute systemic toxicity | ISO 10993-11:2017 | Non-Subchronic systemic toxicity | | Pass | | 2.5 | Subchronic systemic toxicity | ISO 10993-11:2017 | Non-Acute systemic toxicity | | Pass | #### VIII Clinical Test Conclusion No clinical study is included in this submission. ### IX Conclusion The conclusions drawn from the nonclinical tests demonstrate that the Pre-Sintered Zirconia Coloring Liquid is as safe as effective, and performs as well as or better than the legally marketed device.