(76 days)
HT-plus, ST, ST-C, ST-ML, SHT-C, SHT-ML, 3D-Pro-ML are intended for the manufacturing of metal-free partial and single crowns, full arch occlusally screwed bridges, inlays, and veneers, full contour restorations as well as reduced structures in combination with veneering ceramics. The products are categorized into class 5 according to ISO 6872.
UT, UT-C, UT-ML are intended for the manufacturing of metal-free partial and single crowns, max. 3-unit bridges, inlays, onlays and veneers, full contour restorations as well as for reduced structures in combination with veneering ceramics and implant superstructures for 3-unit restorations in the anterior tooth region. The products have to be categorized as class 4 according to ISO 6872.
The products are suitable for CAD/CAM milling machines which are able to process presintered zirconia and which have the proper clamping device for the corresponding block.
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is composed of yttria-stabilized zirconia. The yttria-stabilized zirconia has a long history of safe use in dentistry.
Bloomden Dental Zirconia Blank is white, and it is composed of ZrO2+HfQz+Y2O3 and additional other oxides. Bloomden Dental Zirconia Pre-Shaded Blank is color (containing 20 available Vita shades), and it contains not only the ingredients same as the white zirconia blank but also very small amount of additional inorganic pigments (Fe2O3+E12O3+MnO). The inorganic pigments generate the color on the restorations, after sintering at dental labs, that matches natural color of patient's teeth. And there are two color representations (i.e. monolayer and multilayer) for the color zirconia blank.
The proposed device is provided in various translucency (High-plus Translucency, Super Translucency, Super-high Translucency, Ultra Translucency and 3D-Pro-ML). It also offers various shapes and dimensions suitable for different milling systems.
The proposed device is processed into the dental restorations such as crowns, bridges, veneers, inlays and onlays based on the anatomical rendering of the patient's teeth using CAD/CAM (computer aided design / computer aided manufacturing) method.
The performance of the proposed device conforms to ISO 6872:2015 Dentistry: Ceramic Materials.
The proposed device is a single-use device, and provided non-sterile.
The provided text describes the acceptance criteria and a study demonstrating that the "Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank" device meets these criteria. This device is a dental material and not an AI/ML powered device, hence many of the requested fields are not applicable.
Here's the breakdown of the information:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance was evaluated against the requirements specified in ISO 6872:2015 Dentistry - Ceramic materials.
| Test Item | Acceptance Criteria (from ISO 6872:2015) | Reported Device Performance (UT, UT-C, UT-ML) | Reported Device Performance (HT-plus, ST, ST-C, ST-ML, SHT, SHT-C, SHT-ML, 3D-Pro-ML) | Judgment |
|---|---|---|---|---|
| Uniformity | Uniform | Uniform | Uniform | Pass |
| Freedom from extraneous materials | Free from extraneous materials | Free from extraneous materials | Free from extraneous materials | Pass |
| Radioactivity | <0.02 Bq.g$^{-1}$ (Implicit based on predicate comparison in Table 1, and actual measured values) | <0.02 Bq.g$^{-1}$ | <0.02 Bq.g$^{-1}$ | Pass |
| Flexural strength | UT, UT-C, UT-ML: $\geq$ 500 MPa | 864.3 MPa | 1238.2 MPa | Pass |
| HT-plus, ST, ST-C, ST-ML, SHT, SHT-C, SHT-ML, 3D-Pro-ML: $\geq$ 800 MPa | ||||
| Chemical solubility | $<$ 100 µg.cm$^{-2}$ | 13.5 µg.cm$^{-2}$ | 11.8 µg.cm$^{-2}$ | Pass |
| Linear thermal expansion coefficient | (10.5 $\pm$ 0.5) $\times$ 10$^{-6}$ K$^{-1}$ | 10.0 $\times$ 10$^{-6}$ K$^{-1}$ | 10.5 $\times$ 10$^{-6}$ K$^{-1}$ | Pass |
| Shrinkage factor | Not explicitly stated as a single value criterion, but expected to be consistent within a range | 1.244, 1.243, 1.243 | 1.244, 1.245, 1.241 | Pass |
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated in the provided text for each specific test. The phrase "the test results showed that the proposed device meets the requirements specified in the standard" implies that sufficient samples were tested to satisfy the ISO standard, but the exact numbers are not detailed.
- Data provenance: The tests were "performed according to ISO 6872:2015 Dentistry - Ceramic materials" and "ISO 7405:2018 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry". The location where these non-clinical tests were conducted is not specified beyond the applicant's address in Hunan, China. The data is non-clinical performance testing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable as the study involved non-clinical performance and biocompatibility testing of a material, not the evaluation of a diagnostic device or algorithm requiring expert ground truth for interpretation.
4. Adjudication method for the test set:
Not applicable, as this was non-clinical laboratory testing against ISO standards, not a study requiring human adjudication of results.
5. 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. This device is a dental material, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a dental material, not an algorithm.
7. The type of ground truth used:
For the performance tests, the "ground truth" was established by the requirements and methodologies outlined in the ISO 6872:2015 standard. For biocompatibility, the "ground truth" was established by the requirements and methodologies outlined in the ISO 7405:2018 and ISO 10993 series standards. These are objective, quantitative measures of material properties and biological responses.
8. The sample size for the training set:
Not applicable. This is a material, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 15, 2021
Bloomden Bioceramics (HuNan) Co., Ltd Grace Liu Consultant Shenzhen Joyantech Consulting Co. Ltd 1713A, 17th Floor, Block A, Zhongguan Times Square Nanshan District Shenzhen, Guangdong 518000 CHINA
Re: K212765
Trade/Device Name: Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: August 23, 2021 Received: August 31, 2021
Dear Grace 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 (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.
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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 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 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.
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
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Indications for Use
510(k) Number (if known)
Device Name
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Indications for Use (Describe)
HT-plus, ST, ST-C, ST-ML, SHT-C, SHT-ML, 3D-Pro-ML are intended for the manufacturing of metal-free partial and single crowns, full arch occlusally screwed bridges, inlays, and veneers, full contour restorations as well as reduced structures in combination with veneering ceramics. The products are categorized into class 5 according to ISO 6872.
UT, UT-C, UT-ML are intended for the manufacturing of metal-free partial and single crowns, max. 3-unit bridges, inlays, onlays and veneers, full contour restorations as well as for reduced structures in combination with veneering ceramics and implant superstructures for 3-unit restorations in the anterior tooth region. The products have to be categorized as class 4 according to ISO 6872.
The products are suitable for CAD/CAM milling machines which are able to process presintered zirconia and which have the proper clamping device for the corresponding block.
| 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) |
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Version: A/0
K212765 510(k) Summary
1. Contact Details
1.1 Applicant information
| Applicant Name | Bloomden Bioceramics (HuNan) Co., Ltd | |
|---|---|---|
| Address | No.301, 5th Building, Hi-tech Int'l Enterprise Port, LianDong U Valley, | |
| Linyu Rd, Dongfanghong Street, Hi-tech Development Zone, Changsha, | ||
| HuNan, China | ||
| Contact person | Shengyong Liao | |
| Phone No. | +86-15874253042 | |
| 819441390@qq.com | ||
| Date Prepared | 2021-10-14 | |
1.2 Submission Correspondent
| Shenzhen Joyantech Consulting Co., Ltd1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District,Shenzhen, Guangdong Province, China | |
|---|---|
| 卓远天成 | |
| Phone No. | +86-755-86069197 |
| Contact person | Grace Liu; Field Fu; |
| Contact person's e-mail | grace@cefda.com; field@cefda.com |
| Website | http://www.cefda.com |
2. Device Information
| Trade name | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank |
|---|---|
| Common name | Dental Zirconia Ceramics |
| Model | HT-plus, ST, ST-C, ST-ML, SHT, SHT-C, SHT-ML, 3D-Pro-ML, UT, UT-C, UT-ML |
| Classification | II |
| Classification name | Porcelain powder for clinical use |
| Product code | EIH |
| Regulation No. | 21 CFR 872.6660 |
3. Legally Marketed Predicate Device
| Trade Name | PRETTAU®, ICE and Z-WHITE zirconia blanks |
|---|---|
| 510(k) Number | K183304 |
| Product Code | EIH |
| Manufacturer | ZIRKONZAHN SRL |
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4. Device Description
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is composed of yttria-stabilized zirconia. The yttria-stabilized zirconia has a long history of safe use in dentistry.
Bloomden Dental Zirconia Blank is white, and it is composed of ZrO2+HfQz+Y2O3 and additional other oxides. Bloomden Dental Zirconia Pre-Shaded Blank is color (containing 20 available Vita shades), and it contains not only the ingredients same as the white zirconia blank but also very small amount of additional inorganic pigments (Fe2O3+E12O3+MnO). The inorganic pigments generate the color on the restorations, after sintering at dental labs, that matches natural color of patient's teeth. And there are two color representations (i.e. monolayer and multilayer) for the color zirconia blank.
The proposed device is provided in various translucency (High-plus Translucency, Super Translucency, Super-high Translucency, Ultra Translucency and 3D-Pro-ML). It also offers various shapes and dimensions suitable for different milling systems.
The proposed device is processed into the dental restorations such as crowns, bridges, veneers, inlays and onlays based on the anatomical rendering of the patient's teeth using CAD/CAM (computer aided design / computer aided manufacturing) method.
The performance of the proposed device conforms to ISO 6872:2015 Dentistry: Ceramic Materials.
The proposed device is a single-use device, and provided non-sterile.
5. Intended Use/Indication for Use
HT-plus, ST, ST-C, ST-ML, SHT-C, SHT-ML, 3D-Pro-ML are intended for the manufacturing of metal-free partial and single crowns, full arch occlusally screwed bridges, inlays, onlays, and veneers, full contour restorations as well as reduced structures in combination with veneering ceramics. The products are categorized into class 5 according to ISO 6872.
UT, UT-C, UT-ML are intended for the manufacturing of metal-free partial and single crowns, max. 3-unit bridges, inlays, onlays and veneers, full contour restorations as well as for reduced structures in combination with veneering ceramics and implant superstructures for 3-unit restorations in the anterior and posterior tooth region. The products have to be categorized as class 4 according to ISO 6872.
The products are suitable for CAD/CAM milling machines which are able to process presintered zirconia and which have the proper clamping device for the corresponding block.
6. Substantial Equivalence Comparison
| Comparisonitem | Proposed Device | Predicate Device (K183304) | Comment |
|---|---|---|---|
| Manufacturer | Bloomden Bioceramics (HuNan)Co., Ltd | ZIRKONZAHN SRL | None |
Table 1 Substantial Equivalence Comparison
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| Product Name | Bloomden Dental Zirconia Blank& Dental Zirconia Pre-ShadedBlank | PRETTAU®, ICE and Z-WHITEzirconia blanks | None |
|---|---|---|---|
| Product Code | EIH | EIH | Same |
| RegulationNumber | 21 CFR § 872.6660 | 21 CFR § 872.6660 | Same |
| Classification | Class II | Class II | Same |
| PrescriptionUse | Yes | Yes | Same |
| Indications forUse | HT-plus, ST, ST-C, ST-ML, SHT,SHT-C, SHT-ML, 3D-Pro-ML areintended for the manufacturing ofmetal-free partial and singlecrowns, full arch occlusallyscrewed bridges, inlays, onlays,and veneers, full contourrestorations as well as reducedstructures in combination withveneeringceramics. Theproducts are categorized intoclass 5 according to ISO 6872.UT, UT-C, UT-ML are intended forthe manufacturing of metal-freepartial and single crowns, max.3-unit bridges, inlays, onlays andveneers, full contour restorationsas well as for reduced structuresin combination with veneeringceramics and implantsuperstructures for 3-unitrestorations in the anterior andposterior tooth region. Theproducts have to be categorizedas class 4 according to ISO 6872.The products are suitable forCAD/CAM milling machineswhich are able to processpresintered zirconia and whichhave the proper clamping devicefor the corresponding block. | Prettau®, Prettau® 2, Prettau® 2Coloured, Prettau® 2 Dispersive,ICE Translucent, ICE Premium,ICE Abutment, ICE TranslucentPlus, ICE Translucent PlusColoured, ICE Translucent PlusDispersive and Z-White areintended for the manufacturing ofmetal-free partial and singlecrowns, full arch occlusallyscrewed bridges, inlays, onlays,and veneers, full contourrestorations as well as reducedstructures in combination withveneering ceramics. Theproducts are categorized intoclass 5 according to ISO 6872.Prettau® 3, Prettau® 3 Coloured,Prettau® 3 Dispersive, Prettau® 4Anterior®, Prettau® 4 Anterior®Coloured and Prettau® 4Anterior® Dispersive are destinedfor the manufacturing ofmetal-free partial and singlecrowns, max. 3-unit bridges,inlays, onlays and veneers, fullcontour restorations as well as forreduced structures incombination with veneeringceramics and implantsuperstructures for 3-unitrestorations in the anterior andposterior tooth region. The | Similar |
| products have to be categorized as class 4 according to ISO 6872. The products have been developed for use with Colour Liquid, ICE Zirkon Ceramics, ICE Zirkon Stains and ICE Zirkon Stains 3D. Observe the relative instructions of use when using these products. The blocks are suitable for all milling units, which are able to process presintered zirconia and which have the proper clamping device for the corresponding block. | |||
| Class(per ISO6872:2015) | Class 4UT, UT-C, UT-MLClass 5HT-plus, ST, ST-C, ST-ML, SHT,SHT-C, SHT-ML, 3D-Pro-ML | Class 4Prettau® 3, Prettau® 4 AnteriorClass 5Prettau®, Prettau® 2, ICE group,Z-White | Same |
| Composition | Based on yttria-stabilized zirconia | Based on yttria-stabilized zirconia | Similar |
| Color | White, Color | White, Color | Similar |
| Intended User | Professional dental technicians | Professional dental technicians | Same |
| Single Use | Yes | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| PhysicalProperties | Conform to ISO 6872:2015 | Conform to ISO 6872:2015 | Same |
| Uniformity | Uniform | Uniform | Same |
| Freedom fromextraneousmaterials | Free from extraneous materials | Free from extraneous materials | Same |
| Radioactivity | $≤$ 1.0 Bq.g-1 | $≤$ 1.0 Bq.g-1 | Same |
| Flexuralstrength | UT, UT-C, UT-ML:$≥$ 500 MPaHT-plus, ST, ST-C, ST-ML,SHT, SHT-C, SHT-ML, 3D-Pro-ML: | Prettau® 3, Prettau® 4Anterior: 600 MPaPrettau®, Prettau® 2, ICEgroup, Z-White:$≥$ 900 MPa | Similar |
| Chemicalsolubility | $≥$ 800 MPa$<$ 100 µg.cm-2 | $<$ 100 µg.cm-2 | Same |
| Linear thermalexpansioncoefficient | |||
| $(10.5\pm0.5)\times10^{-6}K^{-1}$ | Not publicly available | Different | |
| Shrinkagefactor | 1.243±0.002 | Not publicly available | Different |
| Biocompatibility | Conform to ISO 7405:2018 | Conform to ISO 10993-1 | Similar |
| Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
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Version: A/0
The proposed device has the similar indication for use as the predicate device as well as comparable technical and biocompatibility properties and characteristics, and the minor differences don't raise any additional questions for safety and effectiveness, the proposed device is substantially equivalent to the predicate device.
7. Non-clinical Testing
The performance tests were performed according to ISO 6872:2015 Dentistry - Ceramic materials, and the test results showed that the proposed device meets the requirements specified in the standard (see Table 2).
| Test Results | |||
|---|---|---|---|
| Test Item | UT, UT-C, UT-ML | HT-plus, ST, ST-C, ST-ML,SHT, SHT-C, SHT-ML,3D-Pro-ML | Judgment |
| Uniformity | Uniform | Uniform | Pass |
| Freedom fromextraneous materials | Free fromextraneous materials | Free fromextraneous materials | Pass |
| Radioactivity | <0.02 Bq.g $^{-1}$ | <0.02 Bq.g $^{-1}$ | Pass |
| Flexural strength | 864.3 MPa | 1238.2 MPa | Pass |
| Chemical solubility | 13.5 µg.cm $^{-2}$ | 11.8 µg.cm $^{-2}$ | Pass |
| Linear thermalexpansion coefficient | 10.0 ×10 $^{-6}$ K $^{-1}$ | 10.5 ×10 $^{-6}$ K $^{-1}$ | Pass |
| Shrinkage factor | 1.244, 1.243, 1.243 | 1.244, 1.245, 1.241 | Pass |
Table 2 Summary of Performance Testing
The biocompatibility tests were performed according to ISO 7405:2018 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (see Table 3), and the test results showed that the proposed device has no biocompatibility issues.
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Product: Bloomden Dental Zirconia Blank & Dental Zirconia
Pre-Shaded Blank
Version: A/0
| Biological Endpoint | Reference | Test Result |
|---|---|---|
| Cytotoxicity | ISO 10993-5:2009 | No cytotoxicity under the conditions ofthe study |
| Cytotoxicity | 6.2 of ISO 7405:2018 | No cytotoxicity under the conditions ofthe study |
| Cytotoxicity | 6.3 of ISO 7405:2018 | No cytotoxicity under the conditions ofthe study |
| Skin Sensitization | ISO 10993-10:2010 | No skin sensitization under theconditions of the study |
| Oral Mucosa Irritation | ISO 10993-10:2010 | No oral mucosa irritation under theconditions of the study |
| Acute Systemic Toxicity | ISO 10993-11:2017 | No acute systemic toxicity under theconditions of the study |
| Subacute Systemic Toxicity | ISO 10993-11:2017 | No subacute systemic toxicity under theconditions of the study |
| SubchronicSystemic Toxicity | ISO 10993-11:2017 | No subchronic systemic toxicity underthe conditions of the study |
| Genotoxicity | ISO 10993-3:2014 | No genotoxicity under the conditions ofthe study |
| Implantation | ISO 10993-6:2016 | No local effects under the conditions ofthe study |
Table 3 Summary of Biocompatibility Testing
The results of the non-clinical testing demonstrate that the proposed device is equivalent to the predicate device.
8. Clinical Testing
No clinical study is included in this submission.
9. Conclusions
The results of comparing the design specifications and non-clinical testing between the proposed device and the legally marketed predicate device (K183304) show that they are Substantially Equivalent (SE).
§ 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.