(144 days)
This product is indicated for use as a veneering material for fixed prosthesis in crowns, bridges.
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.
The provided text describes a 510(k) premarket notification for a "Dental Porcelain Powder" device and outlines its acceptance criteria and non-clinical testing results. It does not describe an AI/ML powered medical device, an imaging device, or a study involving human readers. Therefore, many of the requested categories are not applicable to this document.
However, I can extract and present the information that is relevant to the acceptance criteria and non-clinical testing of this specific medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| ID# | Test | Method | Acceptance Criteria | Reported Device Performance | Conclusion |
|---|---|---|---|---|---|
| 1.1 | Chemical composition of powder | Ingredient content analysis | 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% | Met Product Technical Requirements | Pass |
| 1.2 | Uniformity | Visual inspection after mixing/stirring | Porcelain Powder: After mixing with blending liquid, no pigment separation.Stain/Glaze: After stirring evenly, no pigment separation. | Met Product Technical Requirements | Pass |
| 1.3 | Specification | Weight measurement | Porcelain Powder: (20g, 50g, 100g) ±0.5g/bottle.Stain/Glaze: (2g, 4g, 6g, 8g, 10g, 20g, 50g, 100g) ±0.5g/bottle. | Met Product Technical Requirements | Pass |
| 1.4 | No foreign body | Visual inspection | Porcelain Powder, Stain/Glaze, Blending liquid should not be visible foreign bodies. | Met Product Technical Requirements | Pass |
| 1.5 | Radioactivity | Measurement of active concentration | Porcelain Powder and Stain/Glaze: active concentration of uranium-238 should be ≤1.0 Bq·g⁻¹. | Met Product Technical Requirements | Pass |
| 1.6 | Mixing and compacting properties | Evaluation during mixing and drying | When 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. | Met Product Technical Requirements | Pass |
| 1.7 | Flexural strength | Mechanical testing | Porcelain Powder, Stain/Glaze: should be ≥50 MPa. | Met Product Technical Requirements | Pass |
| 1.8 | Chemical solubility | Chemical testing | Porcelain Powder, Stain/Glaze: should be <100 ug·cm⁻². | Met Product Technical Requirements | Pass |
| 1.9 | Linear expansion coefficient | Thermal testing | Porcelain Powder, Stain/Glaze: should be (10.3±0.5) ×10⁻⁶K⁻¹. | Met Product Technical Requirements | Pass |
| 1.10 | Glass transition temperatures | Thermal testing | Porcelain Powder, Stain/Glaze: should be (588±20)°C. | Met Product Technical Requirements | Pass |
| 1.11 | Bonding strength of veneer porcelain | Mechanical testing | Porcelain Powder, Stain/Glaze: should be >20 MPa. | Met Product Technical Requirements | Pass |
| 1.12 | Blending liquid appearance | Visual inspection | There should be no visible foreign body. | Met Product Technical Requirements | Pass |
| 1.13 | Blending liquid specification | Volume measurement | It should be ±1 mL. | Met Product Technical Requirements | Pass |
| 2.1 | Cytotoxicity | ISO 10993-5:2009 | Non-cytotoxic | Non-cytotoxic | Pass |
| 2.2 | Delayed hypersensitivity | ISO 10993-10:2010 | Non-Delayed hypersensitivity | Non-Delayed hypersensitivity | Pass |
| 2.3 | Intradermal reaction | ISO 10993-10:2010 | Non-Intradermal reaction | Non-Intradermal reaction | Pass |
| 2.4 | Acute systemic toxicity | ISO 10993-11:2017 | Non-Acute systemic toxicity | Non-Acute systemic toxicity | Pass |
| 2.5 | Subchronic systemic toxicity | ISO 10993-11:2017 | Non-Acute systemic toxicity | Non-Acute systemic toxicity | Pass |
| 2.6 | Genotoxicity | ISO 10993-3:2014 | Non-genotoxicity | Non-genotoxicity | Pass |
Since this is not an AI/ML-powered or imaging device, the following categories are not applicable to the provided document. The device is a "Dental Porcelain Powder" and the testing described is non-clinical bench testing and biocompatibility testing.
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for this type of non-clinical, bench testing. The document does not specify sample sizes for individual tests but rather the acceptance criteria for material properties.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for material properties is established by standardized testing methods, not expert consensus in this context.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. No AI component.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm involved.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Ground truth for the non-clinical tests is based on the specified physical, chemical, and biological properties as defined by relevant ISO standards and product technical requirements.
- The sample size for the training set: Not applicable. There is no training set as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
{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 TianfuInternational Bio-Town, Shuangliu District, Chengdu, Sichuan610200, P.R.China |
|---|---|
| Contact Person: | Moushan Liu (Mr.)ManagerPhone: +86-28-88415850E-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
| DeviceCharacteristic | Subject Device | Predicate Device(K060441, K052710) | Discussion |
|---|---|---|---|
| Trade name | Dental Porcelain Powder | Vita VM® | N/A |
| Product code | EIH | EIH | Identical |
| RegulationNumber | 21 CFR 872.6660 | 21 CFR 872.6660 | Identical |
| Regulatoryclass | Class II | Class II | Identical |
| Manufacturer | Chengdu Besmile MedicalTechnology Co., Ltd. | VITA Zahnfabrik H.Rauter Gmbh &Co.KG | N/A |
| Materials | This product includes PorcelainPowder, Stain/Glaze andBlending liquid. The porcelainpowder is composed of silica(SiO2), alumina (Al2O3),potassium oxide (K₂O), sodiumoxide (Na2O), boron trioxide(B2O3), calcium oxide (CaO),barium oxide (BaO), zirconia(ZrO2), zinc oxide (ZnO) , lithiumoxide (Li2O), tin oxide (SnO2),magnesium oxide (MgO), Yttriumoxide (Y2O3) and terbium oxide(Tb2O3). The blending liquid iscomposed of purified water, 1,3-butanediol and diethanolamine.The Stain/Glaze is composed ofthe porcelain powder and theblending liquid in accordancewith the mass ratio of 1:1 | SiO2, Al2O3, K2O, Na2O, Li2O,ZrO2, BaO, CaO, Tb2O3, MgO,TiO2, B2O3, SnO2, Y2O3, ZnO. | DifferentComment 1 |
| Device design | The product form is PorcelainPowder, Stain/Glaze andBlending liquid | The product form is powder, mixedliquid | SimilarComment 2 |
| Conditions ofuse | Made by professionaltechnicians; This product isused by trained professionaloperators in legitimate andlegitimate customized denture | Made by professional technicians;Used by professional dentists | Identical |
| DeviceCharacteristic | Subject Device | Predicate Device(K060441, K052710) | Discussion |
| production institutions. | |||
| Uniformity: PorcelainPowder:After mixing with theblending liquid, there should beno pigment separation.Stain/Glaze:After stirring evenly,there should be no pigmentseparation. | |||
| No foreign body : PorcelainPowder, Stain/Glaze andBlending liquid should be free offoreign bodies. | |||
| Physicochemical properties | Mixing and compactingproperties : Porcelain powdermixed with the blending liquid,should not agglomerate orclumps.The blended paste, afterbeing compacted by layers,should not crack or wrinkle duringthe 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 100MPaConversion temperature: about600°C | SimilarComment 3 |
| Radioactivity: Porcelain Powderand Stain/Glaze: The activeconcentration of uranium-238should be≤1.0 Bq·g-1. | Softening point: about 670°C | ||
| Chemical solubility: 10µg·cm-2 | |||
| Average particle size - Essenceporcelain: approx.18 µm(d50) | |||
| Coefficient of linear expansion:Porcelain Powder , Stain/Glaze:should be(10.3±0.5)×10-6 K-1. | |||
| Flexural strength: PorcelainPowder , Stain/Glaze: should be≥50 MPa. | |||
| Glass transition temperature:Porcelain Powder , Stain/Glaze:should be (588±20)°C. | |||
| Chemical solubility: PorcelainPowder , Stain/Glaze: should be< 100 µg·cm-2 | |||
| DeviceCharacteristic | Subject Device | Predicate Device(K060441, K052710) | Discussion |
| Bonding strength of veneerporcelain: Porcelain Powder,Stain/Glaze: should be $> 20$ MPa. | |||
| Indications use | This product is indicated for useas a veneering material for fixedprosthesis in crowns, bridges. | Vita VM® porcelains are indicatedfor use as a veneering material forfixed prosthesis in crowns, bridges,and dental implant abutments.These devices are used inprosthetic dentistry by forming aporcelain veneer on to a ceramicor metal substructure into theshape of a dental crown. | SimilarComment 4 |
| Workingprinciple | (1) Prepare tools such as knife,coloring pen, palette and so onbefore use;(2) According to the specificsituation of the patient who needsto repair, select the type, colornumber of suitable PorcelainPowder, Stain/Glaze material;(3) Use the blending liquid andporcelain powder to meet theoperating habits, and then carryout the stacking and sinteringoperation according to thepre-designed shape of therestoration;(4) Polishing, thoroughly stirringthe Stain/Glaze, applying theStain/Glaze and sintering againto obtain the final all ceramicdenture restoration. | The product is a material formaking dentures. Firstly, the dentalmold is designed and madeaccording to the specific situationof the patient, and then the dentalmold is shaped, sintered, polished,and finally glazed and sintered tocomplete the production of theprosthesis. | SimilarComment 5 |
| Manufacturingmaterial | Glass ceramics | Glass ceramics | Identical |
| Categorizationby nature ofbody contact | Surface-contacting medicaldevicesMucosal membranes | Surface-contacting medicaldevicesMucosal membranes | Identical |
| Categorizationby duration of | Long-term exposure- contacttime exceeds 30 d | Long-term exposure | Identical |
| DeviceCharacteristic | Subject Device | Predicate Device(K060441, K052710) | Discussion |
| contact | |||
| Applicablepopulation | It is suitable for clinical patientswith denture defect or absence. | It is suitable for clinical patientswith denture defect or absence. | Identical |
| Intended site | Patient's oral cavity | Patient's oral cavity | Identical |
| Target user | This product is used by trainedprofessional operators inlegitimate and legitimatecustomized denture productioninstitutions. | Professional technician | Identical |
| Intended useenvironment | This product is expected to beused in legal and formal customdenture manufacturinginstitutions, and has no specialrequirements on theenvironment. | 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 | AcceptanceCriteria | Conclusion | |
|---|---|---|---|---|---|
| 1 | Physical Testing of Dental Porcelain Powder | ||||
| 1.1 | Chemicalcomposition ofpowder | Ingredient | Content (%) | Producttechnicalrequirements | Pass |
| Silicon dioxide(SiO2) | 57-67 | ||||
| Aluminumoxide (Al2O3) | 10 ~ 20 | ||||
| Potassiumoxide (K2O) | 5 ~ 15 | ||||
| Sodium oxide(Na2O) | 3 ~ 10 | ||||
| Boron trioxide(B2O3) | 3 ~ 6 | ||||
| Calcium oxide(CaO) | < 3 | ||||
| Barium oxide(BaO) | < 3 | ||||
| Zirconiumdioxide (ZrO2) | < 3 | ||||
| Zinc oxide(ZnO) | < 3 | ||||
| Other oxides | < 2 | ||||
| 1.2 | Uniformity | Porcelain Powder:After mixing with theblending liquid, there should be nopigment separation;Stain/Glaze: After stirring evenly,thereshould be no pigment separation. | Producttechnicalrequirements | 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. | Producttechnicalrequirements | Pass | |
| 1.4 | No foreign body | Porcelain Powder, Stain/Glaze,Blending liquid should not be visibleforeign bodies. | Producttechnicalrequirements | Pass | |
| 1.5 | Radioactivity | Porcelain Powder and Stain/Glaze: theactive concentration of uranium-238should be ≤1.0 Bq·g⁻¹ | Producttechnicalrequirements | Pass | |
| 1.6 | Mixing andcompactingproperties | When the porcelain powder is mixedwith the blending liquid, it should not becaked or clumped. The blended paste,after being compacted layer by layer,should not crack or wrinkle during thedrying process. | Producttechnicalrequirements | Pass | |
| 1.7 | Flexural strength | Porcelain Powder , Stain/Glaze: shouldbe ≥50 MPa. | Producttechnicalrequirements | Pass | |
| 1.8 | Chemical solubility | Porcelain Powder , Stain/Glaze: shouldbe <100 ug·cm⁻². | Producttechnicalrequirements | Pass | |
| 1.9 | Linear expansioncoefficient | Porcelain Powder , Stain/Glaze: shouldbe (10.3±0.5) ×10⁻⁶K⁻¹. | Producttechnicalrequirements | Pass | |
| 1.10 | Glass transitiontemperatures | Porcelain Powder , Stain/Glaze: shouldbe (588±20)°C. | Producttechnicalrequirements | Pass | |
| 1.11 | Bonding strength ofveneer porcelain | Porcelain Powder , Stain/Glaze: shouldbe >20 MPa. | Producttechnicalrequirements | Pass | |
| 1.12 | Blending liquidappearance | There should be no visible foreign body. | Producttechnicalrequirements | Pass | |
| 1.13 | Blending liquidspecification | It should be ±1 mL | Producttechnicalrequirements | Pass | |
| 2 Biocompatibility Testing | |||||
| 2.1 | Cytotoxicity | ISO 10993-5:2009 | Non-cytotoxic | Pass | |
| 2.2 | Delayedhypersensitivity | ISO 10993-10:2010 | Non-Delayedhypersensitivity | Pass | |
| 2.3 | Intradermalreaction | ISO 10993-10:2010 | Non-Intradermalreaction | Pass | |
| 2.4 | Acute systemictoxicity | ISO 10993-11:2017 | Non-Acute systemictoxicity | Pass | |
| 2.5 | Subchronicsystemic toxicity | ISO 10993-11:2017 | Non-Acute systemictoxicity | 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.
§ 872.6660 Porcelain powder for clinical use.
(a)
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.(b)
Classification. Class II.