Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

K212765 · Bloomden Bioceramics (HuNan) Co., Ltd. · EIH · Nov 15, 2021 · Dental

Device Facts

• Record ID: K212765
• Device Name: Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
• Applicant: Bloomden Bioceramics (HuNan) Co., Ltd.
• Product Code: EIH · Dental
• Decision Date: Nov 15, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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, 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.

Device Story

Yttria-stabilized zirconia blanks (white or pre-shaded with inorganic pigments) used by professional dental technicians in dental labs; processed via CAD/CAM milling machines to create dental restorations (crowns, bridges, veneers, inlays, onlays). Device input is digital anatomical rendering of patient teeth; output is milled zirconia restoration. Benefits include metal-free, biocompatible, natural-appearing tooth replacements. Single-use, non-sterile.

Clinical Evidence

No clinical data. Bench testing only. Performance testing per ISO 6872:2015 confirmed uniformity, radioactivity, flexural strength, chemical solubility, thermal expansion, and shrinkage factor. Biocompatibility testing per ISO 7405:2018 and ISO 10993 series confirmed no cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, or adverse implantation effects.

Technological Characteristics

Yttria-stabilized zirconia (ZrO2, HfO2, Y2O3) with optional inorganic pigments (Fe2O3, Er2O3, MnO). Solid block form factor for CAD/CAM milling. Non-sterile, single-use. Conforms to ISO 6872:2015 (Class 4 and 5).

Indications for Use

Indicated for manufacturing metal-free partial/single crowns, full arch occlusally screwed bridges, inlays, onlays, veneers, full contour restorations, and reduced structures with veneering ceramics. UT/UT-C/UT-ML models also indicated for 3-unit bridges and implant superstructures in anterior/posterior regions. For use by professional dental technicians.

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

• PRETTAU®, ICE and Z-WHITE zirconia blanks (K183304)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

K212765

#### 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) | |
|--------------------------------------------------------------------------------------|--|
| <span style="font-size: 10pt;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | |
| <span style="font-size: 10pt;">□</span> 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. | [phone] | |
| E-mail | [e-mail] | |
| Date Prepared | 2021-10-14 | |
| | | |

#### 1.2 Submission Correspondent

| | Shenzhen Joyantech Consulting Co., Ltd<br>1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District,<br>Shenzhen, Guangdong Province, China |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 卓远天成 |
| | |
| Phone No. | [phone] |
| Contact person | Grace Liu; Field Fu; |
| Contact person's e-mail | [e-mail]; [e-mail] |
| 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

| Comparison<br>item | Proposed Device | Predicate Device (K183304) | Comment |
|--------------------|------------------------------------------|----------------------------|---------|
| Manufacturer | Bloomden Bioceramics (HuNan)<br>Co., Ltd | ZIRKONZAHN SRL | None |

Table 1 Substantial Equivalence Comparison

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| Product Name | Bloomden Dental Zirconia Blank<br>& Dental Zirconia Pre-Shaded<br>Blank | PRETTAU®, ICE and Z-WHITE<br>zirconia blanks | None |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product Code | EIH | EIH | Same |
| Regulation<br>Number | 21 CFR § 872.6660 | 21 CFR § 872.6660 | Same |
| Classification | Class II | Class II | Same |
| Prescription<br>Use | Yes | Yes | Same |
| Indications for<br>Use | HT-plus, ST, ST-C, ST-ML, SHT,<br>SHT-C, SHT-ML, 3D-Pro-ML are<br>intended for the manufacturing of<br>metal-free partial and single<br>crowns, full arch occlusally<br>screwed bridges, inlays, onlays,<br>and veneers, full contour<br>restorations as well as reduced<br>structures in combination with<br>veneering<br>ceramics. The<br>products are categorized into<br>class 5 according to ISO 6872.<br>UT, UT-C, UT-ML are intended for<br>the manufacturing of metal-free<br>partial and single crowns, max.<br>3-unit bridges, inlays, onlays and<br>veneers, full contour restorations<br>as well as for reduced structures<br>in combination with veneering<br>ceramics and implant<br>superstructures for 3-unit<br>restorations in the anterior and<br>posterior tooth region. The<br>products have to be categorized<br>as class 4 according to ISO 6872.<br>The products are suitable for<br>CAD/CAM milling machines<br>which are able to process<br>presintered zirconia and which<br>have the proper clamping device<br>for the corresponding block. | Prettau®, Prettau® 2, Prettau® 2<br>Coloured, Prettau® 2 Dispersive,<br>ICE Translucent, ICE Premium,<br>ICE Abutment, ICE Translucent<br>Plus, ICE Translucent Plus<br>Coloured, ICE Translucent Plus<br>Dispersive and Z-White are<br>intended for the manufacturing of<br>metal-free partial and single<br>crowns, full arch occlusally<br>screwed bridges, inlays, onlays,<br>and veneers, full contour<br>restorations as well as reduced<br>structures in combination with<br>veneering ceramics. The<br>products are categorized into<br>class 5 according to ISO 6872.<br>Prettau® 3, Prettau® 3 Coloured,<br>Prettau® 3 Dispersive, Prettau® 4<br>Anterior®, Prettau® 4 Anterior®<br>Coloured and Prettau® 4<br>Anterior® Dispersive are destined<br>for the manufacturing of<br>metal-free partial and single<br>crowns, max. 3-unit bridges,<br>inlays, onlays and veneers, full<br>contour restorations as well as for<br>reduced structures in<br>combination with veneering<br>ceramics and implant<br>superstructures for 3-unit<br>restorations in the anterior and<br>posterior 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<br>(per ISO<br>6872:2015) | Class 4<br>UT, UT-C, UT-ML<br>Class 5<br>HT-plus, ST, ST-C, ST-ML, SHT,<br>SHT-C, SHT-ML, 3D-Pro-ML | Class 4<br>Prettau® 3, Prettau® 4 Anterior<br>Class 5<br>Prettau®, Prettau® 2, ICE group,<br>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 |
| Physical<br>Properties | Conform to ISO 6872:2015 | Conform to ISO 6872:2015 | Same |
| Uniformity | Uniform | Uniform | Same |
| Freedom from<br>extraneous<br>materials | Free from extraneous materials | Free from extraneous materials | Same |
| Radioactivity | $≤$ 1.0 Bq.g-1 | $≤$ 1.0 Bq.g-1 | Same |
| Flexural<br>strength | UT, UT-C, UT-ML:<br>$≥$ 500 MPa<br>HT-plus, ST, ST-C, ST-ML,<br>SHT, SHT-C, SHT-ML, 3D-Pro-<br>ML: | Prettau® 3, Prettau® 4<br>Anterior: 600 MPa<br>Prettau®, Prettau® 2, ICE<br>group, Z-White:<br>$≥$ 900 MPa | Similar |
| Chemical<br>solubility | $≥$ 800 MPa<br>$<$ 100 µg.cm-2 | $<$ 100 µg.cm-2 | Same |
| Linear thermal<br>expansion<br>coefficient | | | |
| | $(10.5\pm0.5)\times10^{-6}K^{-1}$ | Not publicly available | Different |
| Shrinkage<br>factor | 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,<br>SHT, SHT-C, SHT-ML,<br>3D-Pro-ML | Judgment |
| Uniformity | Uniform | Uniform | Pass |
| Freedom from<br>extraneous materials | Free from<br>extraneous materials | Free from<br>extraneous 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 thermal<br>expansion 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 of<br>the study |
| Cytotoxicity | 6.2 of ISO 7405:2018 | No cytotoxicity under the conditions of<br>the study |
| Cytotoxicity | 6.3 of ISO 7405:2018 | No cytotoxicity under the conditions of<br>the study |
| Skin Sensitization | ISO 10993-10:2010 | No skin sensitization under the<br>conditions of the study |
| Oral Mucosa Irritation | ISO 10993-10:2010 | No oral mucosa irritation under the<br>conditions of the study |
| Acute Systemic Toxicity | ISO 10993-11:2017 | No acute systemic toxicity under the<br>conditions of the study |
| Subacute Systemic Toxicity | ISO 10993-11:2017 | No subacute systemic toxicity under the<br>conditions of the study |
| Subchronic<br>Systemic Toxicity | ISO 10993-11:2017 | No subchronic systemic toxicity under<br>the conditions of the study |
| Genotoxicity | ISO 10993-3:2014 | No genotoxicity under the conditions of<br>the study |
| Implantation | ISO 10993-6:2016 | No local effects under the conditions of<br>the 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).