(114 days)
Not Found
No
The device description and intended use focus on the material composition and manufacturing process of dental prostheses, with no mention of AI or ML technologies.
No.
The device is a dental glass ceramic used to create prostheses, which are restorative devices, not therapeutic devices.
No
The device descriptions and intended uses clearly state that these products are materials (Dental glass ceramic) used for creating dental prosthetics (veneers, crowns, etc.) through hot pressing or CAD/CAM systems. There is no mention of diagnostic functions or capabilities.
No
The device description clearly states the product is composed of physical materials (SiO2, Li2O, etc.) and undergoes physical processes (hot pressing, grinding, crystallization). It is a dental glass ceramic, which is a physical material used for prostheses, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for creating dental prostheses (veneers, crowns, etc.) for patients. This is a therapeutic and restorative purpose, not a diagnostic one.
- Device Description: The device is a material (dental glass ceramic) used in the fabrication process of these prostheses. It's a component of the final medical device implanted in the patient's mouth.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device is a material used in the creation of a medical device for treatment.
N/A
Intended Use / Indications for Use
Soreal Press is indicated for single-unit anterior or posterior prostheses and for three-unit prostheses, such as veneers, inlay/onlay, partial crowns, anterior crowns, posterior crowns, using the hot press technique. Soreal CAD is indicated for single-unit anterior or posterior prostheses and for three-unit prostheses, such as veneers, inlay/onlay, partial crowns, anterior crowns, posterior crowns, using the CAD/CAM system.
Product codes
EIH
Device Description
Our products are divided into Soreal Press and Soreal CAD.
Soreal Press is put into the porcelain casting furnace and form it by hot pressing at 915-930 °C, and treatment by sandblasting and glazing.
Soreal CAD is cut by grinding equipment with wet processing, and put into the porcelain casting furnace at 840-850°C for 30 min to secondary crystallization treatment. Then dye it.
They are all composed of SiO2, Li2O, K2O, P2O5, Al2O3 and other oxides. They have a variety of colors, and users can choose the right color to match the patient's natural teeth. In general, our products are also called Dental glass ceramic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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. Biocompatibility testing was performed according to ISO 10933 Biocompatibility, and the test results showed that the proposed device meets the requirements specified in the standard.
Key Metrics
Non-clinical data:
Uniformity: Pass
Freedom of extraneous materials: Pass
Linear thermal expansion coefficient: 11.1 x 10^-6 K^-1 (Pass)
Glass transition temperature: Soreal CAD: 518.4°C; Soreal Press: 515.8°C (Pass)
Chemical solubility (µg/cm²): Soreal CAD values: 22.37, 21.56, 22.38, 19.98, 23.20, 19.37, 20.68, 23.45, 21.76; Soreal Press values: 21.87, 22.56, 21.33, 19.32, 21.21, 19.34, 19.63, 22.41, 24.12, 22.24. Average 21.28 (Pass)
Radioactivity of dental ceramic:
§ 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 the FDA logo, which 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.
May 25, 2023
Shenzhen UP3d Technology Co., Ltd. Judy Zhang Head of Firm 401, Block B, Nanshan Yungu Nanfeng Tower 4093 Liuxian Avenue, Nanshan District Shenzhen, Guangdong 518055 CHINA
Re: K230259
Trade/Device Name: Soreal Press, Soreal CAD Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: April 13, 2023 Received: April 25, 2023
Dear Judy Zhang:
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 -S
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 Soreal CAD Soreal Press
Indications for Use (Describe)
Soreal Press is indicated for single-unit anterior or posterior prostheses and for three-unit prostheses, such as veneers, inlay/onlay, partial crowns, anterior crowns, posterior crowns, using the hot press technique. Soreal CAD is indicated for single-unit anterior or posterior prostheses and for three-unit prostheses, such as veneers,
inlay/onlay, partial crowns, anterior crowns, posterior crowns, using the CAD/CAM system.
| 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
Image /page/3/Picture/1 description: The image shows a logo with an orange geometric shape on the left and the text "云甲科技" on the right. The geometric shape appears to be a stylized representation of a cube or a series of interconnected boxes. The text is in Chinese characters, and the overall design is simple and modern.
510(K) Summary - K230259
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date:
1. Submitter's Information
The submitter of this pre-market notification is:
| Name: | Shenzhen UP3d Technology Co., Ltd. |
|---|---|
| Address: | 401, Block B, Nanshan Yungu Nanfeng Tower |
| 4093 Liuxian Avenue, Nanshan District, Shenzhen, China | |
| Contact person: | Judy Zhang |
| Title: | Head of Firm |
| E-mail: | zhangwanlin@up3d.cn |
| Tel: | 086-13713634397 |
2. Device Identification
| Device/Trade Name: | Soreal Press/Soreal CAD |
|---|---|
| Regulation Number: | 872.6660 |
| Regulation Class: | Class 2 |
| Product Code: | EIH |
| Common Name: | Powder, Porcelain |
3. Predicate Device
| 510(K) number: | K192231 |
|---|---|
| Device Name: | Dental Glass Ceramics Blocks |
| Manufacturer: | Aidite (Qinhuangdao) Technology Co., Ltd. |
| Regulation Number: | 872.6660 |
| Regulation Class: | Class 2 |
| Product Code: | EIH |
| Common Name: | Powder, Porcelain |
4. Device Description
Our products are divided into Soreal Press and Soreal CAD.
Soreal Press is put into the porcelain casting furnace and form it by hot pressing at 915-930 °C, and
treatment by sandblasting and glazing.
Soreal CAD is cut by grinding equipment with wet processing, and put into the porcelain casting furnace at 840-850°C for 30 min to secondary crystallization treatment. Then dye it.
4
Image /page/4/Picture/1 description: The image contains a logo with an abstract geometric shape on the left and Chinese characters on the right. The logo and characters are both in orange color. The characters appear to be the name of a company or organization.
They are all composed of SiO2, Li2O, K2O, P2O5, Al2O3 and other oxides. They have a variety of colors, and users can choose the right color to match the patient's natural teeth. In general, our products are also called Dental glass ceramic.
5. Indication for use
Soreal Press is indicated for single-unit anterior or posterior prostheses and for three-unit prostheses, such as veneers, inlay/onlay, partial crowns, posterior crowns, using the hot press technique.
Soreal CAD is indicated for single-unit anterior or posterior prostheses and for three-unit prostheses, such as veneers, inlay/onlay, partial crowns, anterior crowns, using the CAD/CAM system.
5
Image /page/5/Picture/1 description: The image contains a logo and text. The logo is an abstract shape in orange. To the right of the logo is the text "云甲科技", also in orange. The text appears to be in Chinese.
6. Comparison to Predicate Device
Compared to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device as summarized in the following table
| SE
Comparisons | Proposed Devices
K230259 | Predicate Device
K192231 | Similarities/
Differences | |
|--------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Name | Soreal Press | Dental Glass Ceramics
Blocks | / | |
| Classification | Class 2 | Class 2 | Same | |
| Indications for
Use | Soreal Press is
indicated for
single-unit
anterior or
posterior
prostheses and
for three-unit
prostheses, such as
veneers, inlay/onlay,
partial crowns,
anterior crowns,
posterior
crowns, using the
hot press technique. | Soreal CAD is
indicated for
single-unit
anterior or
posterior
prostheses and
for three-unit
prostheses, such as
veneers, inlay/onlay,
partial crowns,
anterior crowns,
posterior
crowns, using the
CAD/CAM system. | Dental Glass Ceramics
Blocks are indicated for
fabricating all-ceramic
restorations such as
veneers, inlay/onlay, partial
crowns, anterior crowns,
posterior crowns, using the
hot press technique or
CAD/CAM system | Similar Note 1 |
| Materials | SiO2, Li2O,
K2O, P2O5,
Al2O3 and other
oxides | SiO2, Li2O, K2O, Al2O3 and
other oxides | Similar Note 2 | |
| Processing at
Dental lab | Hot Press
(Soreal Press) | Hot Press (Up. Press
Series)
CAD/CAM (Up. CAD Series) | Same | |
| Geometry | Cylinder | Blocks | Similar Note 3 | |
| Dimension | Various | Various | Various | Same |
| Single use | Yes | Yes | Yes | Same |
| Available
color | Various | Various | Various | Same |
| Sterile | Non-sterile | Non-sterile | Non-sterile | Same |
| Uniformity | The colorants
are dispersed
uniformly
throughout the
dental ceramic
material and in
powdered
ceramic
products. | The colorants
are dispersed
uniformly
throughout the
dental ceramic
material and in
powdered
ceramic
products. | Meet the requirements of
ISO 6872:2015 | Same |
| Freedom of
extraneous
materials | Device shall be
free from
extraneous
materials | Device shall be
free from
extraneous
materials | Meet the requirements of
ISO 6872:2015 | Same |
| Radioactivity
of dental
ceramic | 300MPa | >300MPa | Meet the requirements of
ISO 6872:2015 | Similar Note 4 |
| Linear thermal
expansion
coefficient | (10±1.5)×10-6K-1 | (10±1.5)×10-6K-1 | Meet the requirements of
ISO 6872:2015 | Similar Note 5 |
| Glass
transition
temperature | 550±50 °C | 550±50 °C | Meet the requirements of
ISO 6872:2015 | Similar Note 6 |
| Chemical
solubility | 300MPa | Soreal CAD
(MPa) | Soreal Press
(MPa) | Pass |
| | | 389 | 410 | |
| | | 367 | 398 | |
| | | 388 | 386 | |
| | | 365 | 405 | |
| | | 378 | 421 | |
| | | 386 | 436 | |
| | | 377 | 397 | |
| | | 398 | 392 | |
| | | 423 | 427 | |
| | | 385 | 379 | |
10
Image /page/10/Picture/0 description: The image shows a logo with an abstract orange design on the left and Chinese characters on the right. The design on the left appears to be a stylized geometric shape. The Chinese characters on the right are arranged horizontally and are also in orange. The logo is simple and modern, with a focus on the design and the Chinese characters.
Traditional 510(k) Submission of Soreal Press & Soreal CAD
Biocompatibility testing was performed to verify the equivalent safety of the materials that are used.
The Biocompatibility tests were performed according to ISO 10933 Biocompatibility, and the test results showed that the proposed device meets the requirements specified in the standard (see the following Table)
| Test Item | Requirements | Measured data | Conclusion |
|---|---|---|---|
| In Vitro | |||
| Cytotoxicity Test | |||
| (ISO 10993- | |||
| 5:2009) | No Cytotoxicity effect | No Cytotoxicity effect | Pass |
| Irritation Oral | |||
| Mucosa Irritation | |||
| (ISO 10993- | |||
| 10:2010) | Not a primary oral mucosa | ||
| irritant under the | |||
| conditions of the study | Not a primary oral mucosa | ||
| irritant under the conditions | |||
| of the study | Pass | ||
| Skin Sensitization | |||
| (ISO 10993- | |||
| 10:2010) | Not a sensitizer under the | ||
| conditions of the study | Not a sensitizer under the | ||
| conditions of the study | Pass |
11
Image /page/11/Picture/1 description: The image shows the logo for YunJia Technology. The logo consists of an orange abstract shape on the left, followed by the company name in Chinese characters on the right. The overall design is simple and modern, with a focus on the company's name and brand identity.
| Subacute and
Subchronic
Toxicity (ISO
10993-11:2017) | No subacute and
subchronic toxic effects
observed | No subacute and
subchronic toxic effects
observed | Pass |
|---------------------------------------------------------------|----------------------------------------------------------|---------------------------------------------------------|------|
| Genotoxicity
(ISO10993-
3:2014) | No genotoxic effects
observed | No genotoxic effects
observed | Pass |
| Acute Systemic
Toxicity (ISO
10993-11:2017) | No acute Systemic
Toxicity | No acute Systemic Toxicity | Pass |
| Pyrogen (ISO
10993-11:2017) | Meets the requirements
for the absence of
pyrogens | Meets the requirements for
the absence of pyrogens | Pass |
8. Conclusion
Information included in this premarket notification supports the substantial equivalence of the proposed Soreal Press/Soreal CAD. The proposed device has the identical intended use, identical indication for us, identical performance, identical fundamental technology, and identical biocompatibility as the predicate device K192231. The results of the testing support a determination of substantial equivalence.