(76 days)
Not Found
No
The document describes a dental zirconia blank material used in CAD/CAM milling. There is no mention of AI or ML being used in the material itself or the manufacturing process described. The "ML" in some product names likely refers to "Multi-Layer" translucency, not Machine Learning.
No
The device is a dental material (zirconia blank) used for manufacturing dental restorations, not a therapeutic device that directly treats or prevents disease.
No
Explanation: The device is a dental zirconia blank intended for manufacturing dental restorations like crowns, bridges, and veneers using CAD/CAM milling machines. Its purpose is to be fabricated into a restoration, not to diagnose a condition.
No
The device description clearly states it is a physical product (zirconia blanks) used for manufacturing dental restorations, not a software application.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is 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." These are all dental restorations, which are physical devices placed in the mouth.
- Device Description: The description details the composition of the zirconia blanks and how they are processed into dental restorations using CAD/CAM milling. This aligns with the manufacturing of physical dental devices.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. The device's function is to create a physical restoration.
Therefore, the device is a dental material used for creating restorations, not an IVD.
N/A
Intended Use / Indications 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, 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.
Product codes (comma separated list FDA assigned to the subject device)
EIH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth region (anterior and posterior)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional dental technicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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). 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. The results of the non-clinical testing demonstrate that the proposed device is equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Flexural strength:
UT, UT-C, UT-ML: 864.3 MPa
HT-plus, ST, ST-C, ST-ML, SHT, SHT-C, SHT-ML, 3D-Pro-ML: 1238.2 MPa
Chemical solubility: 13.5 µg.cm-2 (UT, UT-C, UT-ML), 11.8 µg.cm-2 (HT-plus, ST, ST-C, ST-ML, SHT, SHT-C, SHT-ML, 3D-Pro-ML)
Linear thermal expansion coefficient: 10.0 ×10-6 K-1 (UT, UT-C, UT-ML), 10.5 ×10-6 K-1 (HT-plus, ST, ST-C, ST-ML, SHT, SHT-C, SHT-ML, 3D-Pro-ML)
Shrinkage factor: 1.244, 1.243, 1.243 (UT, UT-C, UT-ML), 1.244, 1.245, 1.241 (HT-plus, ST, ST-C, ST-ML, SHT, SHT-C, SHT-ML, 3D-Pro-ML)
Radioactivity:
§ 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.
0
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.
1
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
2
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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3
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., Ltd
1713A, 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 |
4
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
| item | Proposed Device | Predicate Device (K183304) | Comment |
|---|---|---|---|
| Manufacturer | Bloomden Bioceramics (HuNan) | ||
| Co., Ltd | ZIRKONZAHN SRL | None |
Table 1 Substantial Equivalence Comparison
5
| Product Name | Bloomden Dental Zirconia Blank
& Dental Zirconia Pre-Shaded
Blank | PRETTAU®, ICE and Z-WHITE
zirconia blanks | None |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product Code | EIH | EIH | Same |
| Regulation
Number | 21 CFR § 872.6660 | 21 CFR § 872.6660 | Same |
| Classification | Class II | Class II | Same |
| Prescription
Use | Yes | Yes | Same |
| Indications for
Use | HT-plus, ST, ST-C, ST-ML, SHT,
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. | Prettau®, Prettau® 2, Prettau® 2
Coloured, Prettau® 2 Dispersive,
ICE Translucent, ICE Premium,
ICE Abutment, ICE Translucent
Plus, ICE Translucent Plus
Coloured, ICE Translucent Plus
Dispersive and Z-White 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.
Prettau® 3, Prettau® 3 Coloured,
Prettau® 3 Dispersive, Prettau® 4
Anterior®, Prettau® 4 Anterior®
Coloured and Prettau® 4
Anterior® Dispersive are destined
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 | 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 ISO
6872:2015) | Class 4
UT, UT-C, UT-ML
Class 5
HT-plus, ST, ST-C, ST-ML, SHT,
SHT-C, SHT-ML, 3D-Pro-ML | Class 4
Prettau® 3, Prettau® 4 Anterior
Class 5
Prettau®, 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 |
| Physical
Properties | Conform to ISO 6872:2015 | Conform to ISO 6872:2015 | Same |
| Uniformity | Uniform | Uniform | Same |
| Freedom from
extraneous
materials | Free from extraneous materials | Free from extraneous materials | Same |
| Radioactivity | $≤$ 1.0 Bq.g-1 | $≤$ 1.0 Bq.g-1 | Same |
| Flexural
strength | UT, UT-C, UT-ML:
$≥$ 500 MPa
HT-plus, ST, ST-C, ST-ML,
SHT, SHT-C, SHT-ML, 3D-Pro-
ML: | Prettau® 3, Prettau® 4
Anterior: 600 MPa
Prettau®, Prettau® 2, ICE
group, Z-White:
$≥$ 900 MPa | Similar |
| Chemical
solubility | $≥$ 800 MPa
$