Who is the manufacturer of Dental Porcelain Powder?

Chengdu Besmile Medical Technology Co., Ltd. filed the 510(k) submission for Dental Porcelain Powder (K232676).

What is the FDA product code for Dental Porcelain Powder?

EIH. It is classified under 21 CFR 872.6660 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Dental Porcelain Powder?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Dental Porcelain Powder?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Dental Porcelain Powder

K232676 · Chengdu Besmile Medical Technology Co., Ltd. · EIH · Jan 23, 2024 · Dental

Device Facts

Record ID	K232676
Device Name	Dental Porcelain Powder
Applicant	Chengdu Besmile Medical Technology Co., Ltd.
Product Code	EIH · Dental
Decision Date	Jan 23, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.6660
Device Class	Class 2

Intended Use

This product is indicated for use as a veneering material for fixed prosthesis in crowns, bridges.

Device Story

Dental Porcelain Powder is a glass ceramic material used by professional technicians in dental laboratories to fabricate fixed prosthetic restorations (crowns, bridges). The device consists of porcelain powder, stain/glaze, and a blending liquid (purified water, 1,3-butanediol, diethanolamine). The technician selects the appropriate powder and color, mixes it with the blending liquid, and stacks the material onto a substructure according to a pre-designed shape. The restoration is then sintered, polished, and glazed to achieve the final all-ceramic denture. The output is a custom-made dental restoration that restores function and aesthetics for patients with tooth defects or absence.

Clinical Evidence

No clinical data. Bench testing only. Performance testing included chemical composition, uniformity, radioactivity, mixing/compacting properties, flexural strength (≥50 MPa), chemical solubility (<100 µg/cm²), linear expansion coefficient, glass transition temperature, and bonding strength (>20 MPa). Biocompatibility testing included cytotoxicity (ISO 10993-5), delayed hypersensitivity (ISO 10993-10), intradermal reaction (ISO 10993-10), acute/subchronic systemic toxicity (ISO 10993-11), and genotoxicity (ISO 10993-3). All tests passed.

Technological Characteristics

Glass ceramic material. Composition: SiO2, Al2O3, K2O, Na2O, B2O3, CaO, BaO, ZrO2, ZnO, Li2O, SnO2, MgO, Y2O3, Tb2O3. Blending liquid: purified water, 1,3-butanediol, diethanolamine. Physical properties: linear expansion coefficient (10.3±0.5)×10⁻⁶K⁻¹, glass transition temperature (588±20)°C, flexural strength ≥50 MPa, chemical solubility <100 µg/cm². Conforms to ISO 6872:2015. Surface-contacting device for long-term mucosal exposure.

Indications for Use

Indicated for use as a veneering material for fixed prosthesis in crowns and bridges in clinical patients with denture defect or absence.

Regulatory Classification

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

Vita VM® (K060441, K052710)

Related Devices

K242400 — Dental porcelain powder · Yilink (Tianjin) Biotechnology Co., Ltd. · Oct 10, 2024
K032416 — VINTAGE PRESS, VINTAGE LF, VINTAGE LF STAIN · Shofu Dental Corp. · Feb 5, 2004
K100150 — CERAMICS2IN1 · Biodenta Swiss AG · May 25, 2010
K981708 — DENTAL PORCELAIN-VARIOUS · Excel Porcelain Products · Jul 23, 1998
K221051 — Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank · Changsha Honchon Technology Co., Ltd. · Jul 8, 2022

Submission Summary (Full Text)

{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. January 23, 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: K232676 Trade/Device Name: Dental Porcelain Powder 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: November 24, 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. 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" {1}------------------------------------------------ (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 OS 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). Sincerely. Bobak Shirmohammadi -S For Michael E. Adjodha, M. ChE., RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices {2}------------------------------------------------ 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) K232676 Device Name Dental Porcelain Powder Indications for Use (Describe) This product is indicated for use as a veneering material for fixed prosthesis in crowns, 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. 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}------------------------------------------------ # 510(k) Summary -K232676 #### 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: +86-28-88415850 E-mail: 79802494@qq.com | #### II Device | Trade Name of Device: | Dental Porcelain Powder | |-----------------------|-------------------------| | Regulation Number: | 21 CFR 872.6660 | | Classification Name: | Powder, Porcelain | | Product Code: | EIH | | Regulatory Class | II | | Review Panel | Dental | #### III Predicate Devices | 510k Number | K060441, K052710 | |-----------------------|-------------------| | Trade Name of Device: | Vita VM® | | Regulation Number: | 21 CFR 872.6660 | | Regulation Name: | Powder, Porcelain | | Regulatory Class | II | | Product Code: | EIH | ## IV Device Description This product includes Porcelain Powder, Stain/Glaze and Blending liquid. The porcelain powder is composed of silica (SiOz), alumina (AlzOs), potassium oxide (K2O), sodium oxide (Na2O), boron trioxide (B2O3), calcium oxide (CaO), barium oxide (BaO), zirconia (ZrO2), zinc oxide (ZnO) , lithium oxide (Li₂O), tin oxide (SnO₂), magnesium oxide (MgO), Yttrium oxide (Y2O3) and terbium oxide (Tb2Os).. The blending liquid is composed of purified water, 1, 3-butanediol and diethanolamine. The Stain/Glaze is composed of the porcelain powder and the blending liquid in accordance with the mass ratio of 1:1. #### V Indications for use This product is indicated for use as a veneering material for fixed prosthesis in crowns, bridges. {5}------------------------------------------------ ## VI Technological Characteristics Comparison VI-1: Comparison of Dental Porcelain Powder | Device Characteristic | Subject Device | Predicate Device (K060441, K052710) | Discussion | |------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------| | Trade name | Dental Porcelain Powder | Vita VM® | N/A | | Product code | EIH | EIH | Identical | | Regulation Number | 21 CFR 872.6660 | 21 CFR 872.6660 | Identical | | Regulatory class | Class II | Class II | Identical | | Manufacturer | Chengdu Besmile Medical Technology Co., Ltd. | VITA Zahnfabrik H.Rauter Gmbh & Co.KG | N/A | | Materials | This product includes Porcelain Powder, Stain/Glaze and Blending liquid. The porcelain powder is composed of silica (SiO2), alumina (Al2O3), potassium oxide (K₂O), sodium oxide (Na2O), boron trioxide (B2O3), calcium oxide (CaO), barium oxide (BaO), zirconia (ZrO2), zinc oxide (ZnO) , lithium oxide (Li2O), tin oxide (SnO2), magnesium oxide (MgO), Yttrium oxide (Y2O3) and terbium oxide (Tb2O3). The blending liquid is composed of purified water, 1, 3-butanediol and diethanolamine. The Stain/Glaze is composed of the porcelain powder and the blending liquid in accordance with the mass ratio of 1:1 | SiO2, Al2O3, K2O, Na2O, Li2O, ZrO2, BaO, CaO, Tb2O3, MgO, TiO2, B2O3, SnO2, Y2O3, ZnO. | Different Comment 1 | | Device design | The product form is Porcelain Powder, Stain/Glaze and Blending liquid | The product form is powder, mixed liquid | Similar Comment 2 | | Conditions of use | Made by professional technicians; This product is used by trained professional operators in legitimate and legitimate customized denture | Made by professional technicians; Used by professional dentists | Identical | | Device Characteristic | Subject Device | Predicate Device (K060441, K052710) | Discussion | | | production institutions. | | | | | Uniformity: Porcelain Powder:After mixing with the blending liquid, there should be no pigment separation. Stain/Glaze:After stirring evenly, there should be no pigment separation. | | | | | No foreign body : Porcelain Powder, Stain/Glaze and Blending liquid should be free of foreign bodies. | | | | Physicochemical properties | Mixing and compacting properties : Porcelain powder mixed with the blending liquid, should not agglomerate or clumps.The blended paste, after being compacted by layers, should not crack or wrinkle during the drying process. | Thermal expansion coefficient (25-500°C) - dentin porcelain: $(8.8-9.2)×10^{-6}K^{-1}$ Three point bending strength - dentine porcelain: about 100MPa Conversion temperature: about 600°C | Similar Comment 3 | | | Radioactivity: Porcelain Powder and Stain/Glaze: The active concentration of uranium-238 should be≤1.0 Bq·g-1. | Softening point: about 670°C | | | | | Chemical solubility: 10µg·cm-2 | | | | | Average particle size - Essence porcelain: approx.18 µm(d50) | | | | Coefficient of linear expansion: Porcelain Powder , Stain/Glaze: should be(10.3±0.5)×10-6 K-1. | | | | | Flexural strength: Porcelain Powder , Stain/Glaze: should be ≥50 MPa. | | | | | Glass transition temperature: Porcelain Powder , Stain/Glaze: should be (588±20)°C. | | | | | Chemical solubility: Porcelain Powder , Stain/Glaze: should be < 100 µg·cm-2 | | | | Device Characteristic | Subject Device | Predicate Device (K060441, K052710) | Discussion | | | Bonding strength of veneer porcelain: Porcelain Powder, Stain/Glaze: should be $> 20$ MPa. | | | | Indications use | This product is indicated for use as a veneering material for fixed prosthesis in crowns, bridges. | Vita VM® porcelains are indicated for use as a veneering material for fixed prosthesis in crowns, bridges, and dental implant abutments. These devices are used in prosthetic dentistry by forming a porcelain veneer on to a ceramic or metal substructure into the shape of a dental crown. | Similar Comment 4 | | Working principle | (1) Prepare tools such as knife, coloring pen, palette and so on before use; (2) According to the specific situation of the patient who needs to repair, select the type, color number of suitable Porcelain Powder, Stain/Glaze material; (3) Use the blending liquid and porcelain powder to meet the operating habits, and then carry out the stacking and sintering operation according to the pre-designed shape of the restoration; (4) Polishing, thoroughly stirring the Stain/Glaze, applying the Stain/Glaze and sintering again to obtain the final all ceramic denture restoration. | The product is a material for making dentures. Firstly, the dental mold is designed and made according to the specific situation of the patient, and then the dental mold is shaped, sintered, polished, and finally glazed and sintered to complete the production of the prosthesis. | Similar Comment 5 | | Manufacturing material | Glass ceramics | Glass ceramics | Identical | | Categorization by nature of body contact | Surface-contacting medical devices Mucosal membranes | Surface-contacting medical devices Mucosal membranes | Identical | | Categorization by duration of | Long-term exposure- contact time exceeds 30 d | Long-term exposure | Identical | | Device Characteristic | Subject Device | Predicate Device (K060441, K052710) | Discussion | | contact | | | | | Applicable population | It is suitable for clinical patients with denture defect or absence. | It is suitable for clinical patients with denture defect or absence. | Identical | | Intended site | Patient's oral cavity | Patient's oral cavity | Identical | | Target user | This product is used by trained professional operators in legitimate and legitimate customized denture production institutions. | Professional technician | Identical | | Intended use environment | This product is expected to be used in legal and formal custom denture manufacturing institutions, and has no special requirements on the environment. | Denture making facility | Identical | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ #### Comment 1 The main ingredients are basically the same, and the product has passed the biocompatibility test, and there are no new risks. #### Comment 2 A stain/glaze is made by mixing a porcelain powder and a blending liquid.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. #### Comment 3 The linear expansion coefficient and glass transition temperature of the Subject Device are Predicate Device Within the range. The chemical solubility, radioactivity and flexural strength of the Subject Device meet the standard ISO 6872:2015 Dentistry-Ceramic materials. The average particle size does not affect safety and effectiveness. In summary, this difference does not affect, essentially equivalent. #### Comment 4 Our indication is covered by the comparison device indication. {9}------------------------------------------------ #### Comment 5 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 Dental Porcelain Powder 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 Dental Porcelain Powder | | | | | 1.1 | Chemical composition of powder | Ingredient | Content (%) | Product technical requirements | Pass | | | | Silicon dioxide (SiO2) | 57-67 | | | | | | Aluminum oxide (Al2O3) | 10 ~ 20 | | | | | | Potassium oxide (K2O) | 5 ~ 15 | | | | | | Sodium oxide (Na2O) | 3 ~ 10 | | | | | | Boron trioxide (B2O3) | 3 ~ 6 | | | | | | Calcium oxide (CaO) | < 3 | | | | | | Barium oxide (BaO) | < 3 | | | | | | Zirconium dioxide (ZrO2) | < 3 | | | | | | Zinc oxide (ZnO) | < 3 | | | | | | Other oxides | < 2 | | | | 1.2 | Uniformity | Porcelain Powder:After mixing with the blending liquid, there should be no pigment separation; Stain/Glaze: After stirring evenly,there should be no pigment separation. | | Product technical requirements | Pass | | 1.3 | Specification | Porcelain Powder: (20g, 50g, 100g) ±0.5g/ bottle; Stain/Glaze: (2g, 4g, 6g, 8g, 10g, 20g, 50g, 100g)±0.5g/ bottle. | Product technical requirements | Pass | | | 1.4 | No foreign body | Porcelain Powder, Stain/Glaze, Blending liquid should not be visible foreign bodies. | Product technical requirements | Pass | | | 1.5 | Radioactivity | Porcelain Powder and Stain/Glaze: the active concentration of uranium-238 should be ≤1.0 Bq·g⁻¹ | Product technical requirements | Pass | | | 1.6 | Mixing and compacting properties | When the porcelain powder is mixed with the blending liquid, it should not be caked or clumped. The blended paste, after being compacted layer by layer, should not crack or wrinkle during the drying process. | Product technical requirements | Pass | | | 1.7 | Flexural strength | Porcelain Powder , Stain/Glaze: should be ≥50 MPa. | Product technical requirements | Pass | | | 1.8 | Chemical solubility | Porcelain Powder , Stain/Glaze: should be <100 ug·cm⁻². | Product technical requirements | Pass | | | 1.9 | Linear expansion coefficient | Porcelain Powder , Stain/Glaze: should be (10.3±0.5) ×10⁻⁶K⁻¹. | Product technical requirements | Pass | | | 1.10 | Glass transition temperatures | Porcelain Powder , Stain/Glaze: should be (588±20)°C. | Product technical requirements | Pass | | | 1.11 | Bonding strength of veneer porcelain | Porcelain Powder , Stain/Glaze: should be >20 MPa. | Product technical requirements | Pass | | | 1.12 | Blending liquid appearance | There should be no visible foreign body. | Product technical requirements | Pass | | | 1.13 | Blending liquid specification | It should be ±1 mL | Product technical requirements | 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-Acute systemic toxicity | Pass | | | 2.5 | Subchronic systemic toxicity | ISO 10993-11:2017 | Non-Acute systemic toxicity | Pass | | | 2.6 | Genotoxicity | ISO 10993-3:2014 | Non-genotoxicity | Pass | | Table VII-1: Performance testing was conducted on the subject device {10}------------------------------------------------ {11}------------------------------------------------ ### VIII Clinical Test Conclusion No clinical study is included in this submission. ## IX Conclusion The conclusions drawn from the nonclinical tests demonstrate that the Dental porcelain powder is as safe and effective as the predicate device.