(144 days)
Not Found
No
The device description focuses on the material composition of a dental veneering material and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are bench tests related to material properties.
No
The device is a veneering material for fixed prostheses like crowns and bridges, designed to replace missing tooth structure and is not intended to treat or cure a disease or condition.
No
Explanation: The product is described as a veneering material for fixed prostheses (crowns, bridges). Its intended use is to create dental restorations, not to diagnose medical conditions or diseases. The description focuses on its chemical composition and performance as a material, not on any diagnostic capabilities.
No
The device description explicitly lists physical components (Porcelain Powder, Stain/Glaze, Blending liquid) and their chemical compositions, indicating it is a material-based device, 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 "as a veneering material for fixed prosthesis in crowns, bridges." This describes a material used in the patient's mouth for restorative purposes, not a test performed on a sample taken from the patient to diagnose a condition.
- Device Description: The components (Porcelain Powder, Stain/Glaze, Blending liquid) are materials used to create a dental restoration. They are not reagents or instruments designed to analyze biological samples.
- Anatomical Site: The anatomical site is the "Patient's oral cavity," which is where the finished product is placed, not where a sample is collected for testing.
- Performance Studies: The performance studies focus on the physical and biological properties of the material itself (flexural strength, chemical solubility, cytotoxicity, etc.), not on its ability to accurately detect or measure a substance in a biological sample.
IVD devices are specifically designed to examine specimens derived from the human body (such as blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
This product is indicated for use as a veneering material for fixed prosthesis in crowns, bridges.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
This product includes Porcelain Powder, Stain/Glaze and Blending liquid. The porcelain powder is composed of silica (SiOz), alumina (AlzOs), potassium oxide (K2O), sodium oxide (Na2O), boron trioxide (B2O3), calcium oxide (CaO), barium oxide (BaO), zirconia (ZrO2), zinc oxide (ZnO) , lithium oxide (Li₂O), tin oxide (SnO₂), magnesium oxide (MgO), Yttrium oxide (Y2O3) and terbium oxide (Tb2Os).. The blending liquid is composed of purified water, 1, 3-butanediol and diethanolamine. The Stain/Glaze is composed of the porcelain powder and the blending liquid in accordance with the mass ratio of 1:1.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Patient's oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
This product is used by trained professional operators in legitimate and legitimate customized denture production institutions.
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 non-clinical testing for Dental Porcelain Powder was performed to demonstrate verification testing in conformance with the acceptance criteria of test methods and recognized consensus standards shown below.
Key results from performance tests include:
- Chemical composition within specified ranges for SiO2, Al2O3, K2O, Na2O, B2O3, CaO, BaO, ZrO2, ZnO, and other oxides.
- Uniformity: no pigment separation after mixing with blending liquid for Porcelain Powder and after stirring for Stain/Glaze.
- Specification: Porcelain Powder (20g, 50g, 100g) ±0.5g/bottle; Stain/Glaze (2g, 4g, 6g, 8g, 10g, 20g, 50g, 100g) ±0.5g/bottle.
- No foreign body visible in Porcelain Powder, Stain/Glaze, Blending liquid.
- Radioactivity: active concentration of uranium-238 ≤1.0 Bq·g⁻¹.
- Mixing and compacting properties: no caking, clumping, cracking, or wrinkling.
- Flexural strength: ≥50 MPa.
- Chemical solubility: 20 MPa.
- Blending liquid appearance: no visible foreign body.
- Blending liquid specification: ±1 mL.
Biocompatibility testing included:
- Cytotoxicity (ISO 10993-5:2009): Non-cytotoxic.
- Delayed hypersensitivity (ISO 10993-10:2010): Non-Delayed hypersensitivity.
- Intradermal reaction (ISO 10993-10:2010): Non-Intradermal reaction.
- Acute systemic toxicity (ISO 10993-11:2017): Non-Acute systemic toxicity.
- Subchronic systemic toxicity (ISO 10993-11:2017): Non-Acute systemic toxicity.
- Genotoxicity (ISO 10993-3:2014): Non-genotoxicity.
All tests passed. No clinical study was included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 23, 2024
Chengdu Besmile Medical Technology Co., Ltd. Moushan Liu Quality Manager No.9, Sec.2, Shengwucheng North Rd., Chengdu Tianfu International Bio-Town, Shuangliu District Chengdu, Sichuan 610200 China
Re: K232676
Trade/Device Name: Dental Porcelain Powder Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: September 1, 2023 Received: November 24, 2023
Dear Moushan Liu:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Bobak Shirmohammadi -S
For Michael E. Adjodha, M. ChE., RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices
2
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232676
Device Name Dental Porcelain Powder
Indications for Use (Describe)
This product is indicated for use as a veneering material for fixed prosthesis in crowns, bridges.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary -K232676
l 510(k) Submitter
| Device Submitter: | Chengdu Besmile Medical Technology Co., Ltd.
No.9,Sec.2, Shengwucheng North Rd., Chengdu Tianfu
International Bio-Town, Shuangliu District, Chengdu, Sichuan
610200, P.R.China |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Moushan Liu (Mr.)
Manager
Phone: +86-28-88415850
E-mail: 79802494@qq.com |
II Device
| Trade Name of Device: | Dental Porcelain Powder |
|---|---|
| Regulation Number: | 21 CFR 872.6660 |
| Classification Name: | Powder, Porcelain |
| Product Code: | EIH |
| Regulatory Class | II |
| Review Panel | Dental |
III Predicate Devices
| 510k Number | K060441, K052710 |
|---|---|
| Trade Name of Device: | Vita VM® |
| Regulation Number: | 21 CFR 872.6660 |
| Regulation Name: | Powder, Porcelain |
| Regulatory Class | II |
| Product Code: | EIH |
IV Device Description
This product includes Porcelain Powder, Stain/Glaze and Blending liquid. The porcelain powder is composed of silica (SiOz), alumina (AlzOs), potassium oxide (K2O), sodium oxide (Na2O), boron trioxide (B2O3), calcium oxide (CaO), barium oxide (BaO), zirconia (ZrO2), zinc oxide (ZnO) , lithium oxide (Li₂O), tin oxide (SnO₂), magnesium oxide (MgO), Yttrium oxide (Y2O3) and terbium oxide (Tb2Os).. The blending liquid is composed of purified water, 1, 3-butanediol and diethanolamine. The Stain/Glaze is composed of the porcelain powder and the blending liquid in accordance with the mass ratio of 1:1.
V Indications for use
This product is indicated for use as a veneering material for fixed prosthesis in crowns, bridges.
5
VI Technological Characteristics Comparison
VI-1: Comparison of Dental Porcelain Powder
| Device
Characteristic | Subject Device | Predicate Device
(K060441, K052710) | Discussion |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Trade name | Dental Porcelain Powder | Vita VM® | N/A |
| Product code | EIH | EIH | Identical |
| Regulation
Number | 21 CFR 872.6660 | 21 CFR 872.6660 | Identical |
| Regulatory
class | Class II | Class II | Identical |
| Manufacturer | Chengdu Besmile Medical
Technology Co., Ltd. | VITA Zahnfabrik H.Rauter Gmbh &
Co.KG | N/A |
| Materials | This product includes Porcelain
Powder, Stain/Glaze and
Blending liquid. The porcelain
powder is composed of silica
(SiO2), alumina (Al2O3),
potassium oxide (K₂O), sodium
oxide (Na2O), boron trioxide
(B2O3), calcium oxide (CaO),
barium oxide (BaO), zirconia
(ZrO2), zinc oxide (ZnO) , lithium
oxide (Li2O), tin oxide (SnO2),
magnesium oxide (MgO), Yttrium
oxide (Y2O3) and terbium oxide
(Tb2O3). The blending liquid is
composed of purified water, 1,
3-butanediol and diethanolamine.
The Stain/Glaze is composed of
the porcelain powder and the
blending liquid in accordance
with the mass ratio of 1:1 | SiO2, Al2O3, K2O, Na2O, Li2O,
ZrO2, BaO, CaO, Tb2O3, MgO,
TiO2, B2O3, SnO2, Y2O3, ZnO. | Different
Comment 1 |
| Device design | The product form is Porcelain
Powder, Stain/Glaze and
Blending liquid | The product form is powder, mixed
liquid | Similar
Comment 2 |
| Conditions of
use | Made by professional
technicians; This product is
used by trained professional
operators in legitimate and
legitimate customized denture | Made by professional technicians;
Used by professional dentists | Identical |
| Device
Characteristic | Subject Device | Predicate Device
(K060441, K052710) | Discussion |
| | production institutions. | | |
| | Uniformity: Porcelain
Powder:After mixing with the
blending liquid, there should be
no pigment separation.
Stain/Glaze:After stirring evenly,
there should be no pigment
separation. | | |
| | No foreign body : Porcelain
Powder, Stain/Glaze and
Blending liquid should be free of
foreign bodies. | | |
| Physicochemical properties | Mixing and compacting
properties : Porcelain powder
mixed with the blending liquid,
should not agglomerate or
clumps.The blended paste, after
being compacted by layers,
should not crack or wrinkle during
the drying process. | Thermal expansion coefficient
(25-500°C) - dentin porcelain:
$(8.8-9.2)×10^{-6}K^{-1}$
Three point bending strength -
dentine porcelain: about 100MPa
Conversion temperature: about
600°C | Similar
Comment 3 |
| | Radioactivity: Porcelain Powder
and Stain/Glaze: The active
concentration of uranium-238
should be≤1.0 Bq·g-1. | Softening point: about 670°C | |
| | | Chemical solubility: 10µg·cm-2 | |
| | | Average particle size - Essence
porcelain: approx.18 µm(d50) | |
| | Coefficient of linear expansion:
Porcelain Powder , Stain/Glaze:
should be(10.3±0.5)×10-6 K-1. | | |
| | Flexural strength: Porcelain
Powder , Stain/Glaze: should be
≥50 MPa. | | |
| | Glass transition temperature:
Porcelain Powder , Stain/Glaze:
should be (588±20)°C. | | |
| | Chemical solubility: Porcelain
Powder , Stain/Glaze: should be
20$ MPa. | | |
| Indications use | This product is indicated for use
as a veneering material for fixed
prosthesis in crowns, bridges. | Vita VM® porcelains are indicated
for use as a veneering material for
fixed prosthesis in crowns, bridges,
and dental implant abutments.
These devices are used in
prosthetic dentistry by forming a
porcelain veneer on to a ceramic
or metal substructure into the
shape of a dental crown. | Similar
Comment 4 |
| Working
principle | (1) Prepare tools such as knife,
coloring pen, palette and so on
before use;
(2) According to the specific
situation of the patient who needs
to repair, select the type, color
number of suitable Porcelain
Powder, Stain/Glaze material;
(3) Use the blending liquid and
porcelain powder to meet the
operating habits, and then carry
out the stacking and sintering
operation according to the
pre-designed shape of the
restoration;
(4) Polishing, thoroughly stirring
the Stain/Glaze, applying the
Stain/Glaze and sintering again
to obtain the final all ceramic
denture restoration. | The product is a material for
making dentures. Firstly, the dental
mold is designed and made
according to the specific situation
of the patient, and then the dental
mold is shaped, sintered, polished,
and finally glazed and sintered to
complete the production of the
prosthesis. | Similar
Comment 5 |
| Manufacturing
material | Glass ceramics | Glass ceramics | Identical |
| Categorization
by nature of
body contact | Surface-contacting medical
devices
Mucosal membranes | Surface-contacting medical
devices
Mucosal membranes | Identical |
| Categorization
by duration of | Long-term exposure- contact
time exceeds 30 d | Long-term exposure | Identical |
| Device
Characteristic | Subject Device | Predicate Device
(K060441, K052710) | Discussion |
| contact | | | |
| Applicable
population | It is suitable for clinical patients
with denture defect or absence. | It is suitable for clinical patients
with denture defect or absence. | Identical |
| Intended site | Patient's oral cavity | Patient's oral cavity | Identical |
| Target user | This product is used by trained
professional operators in
legitimate and legitimate
customized denture production
institutions. | Professional technician | Identical |
| Intended use
environment | This product is expected to be
used in legal and formal custom
denture manufacturing
institutions, and has no special
requirements on the
environment. | Denture making facility | Identical |
6
7
8
Comment 1
The main ingredients are basically the same, and the product has passed the biocompatibility test, and there are no new risks.
Comment 2
A stain/glaze is made by mixing a porcelain powder and a blending liquid.The Indications for Use of the two are only different in the description of the text, and the actual intended use is the same, which does not affect the safety and effectiveness of the product.
Comment 3
The linear expansion coefficient and glass transition temperature of the Subject Device are Predicate Device Within the range.
The chemical solubility, radioactivity and flexural strength of the Subject Device meet the standard ISO 6872:2015 Dentistry-Ceramic materials.
The average particle size does not affect safety and effectiveness.
In summary, this difference does not affect, essentially equivalent.
Comment 4
Our indication is covered by the comparison device indication.
9
Comment 5
The understanding of the product varies between manufacturers, and the Subject Device describes the working principle in more detail.
VII Summary of Non-clinical Testing (Bench)
The non-clinical testing for Dental Porcelain Powder was performed to demonstrate verification testing in conformance with the acceptance criteria of test methods and recognized consensus standards shown below.
| ID# | Test | Method | Acceptance
Criteria | Conclusion | |
|----------------------------|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|--------------------------------------|------|
| 1 | | Physical Testing of Dental Porcelain Powder | | | |
| 1.1 | Chemical
composition of
powder | Ingredient | Content (%) | Product
technical
requirements | Pass |
| | | Silicon dioxide
(SiO2) | 57-67 | | |
| | | Aluminum
oxide (Al2O3) | 10 ~ 20 | | |
| | | Potassium
oxide (K2O) | 5 ~ 15 | | |
| | | Sodium oxide
(Na2O) | 3 ~ 10 | | |
| | | Boron trioxide
(B2O3) | 3 ~ 6 | | |
| | | Calcium oxide
(CaO) | 20 MPa. | Product
technical
requirements | Pass | |
| 1.12 | Blending liquid
appearance | There should be no visible foreign body. | Product
technical
requirements | Pass | |
| 1.13 | Blending liquid
specification | It should be ±1 mL | Product
technical
requirements | Pass | |
| 2 Biocompatibility Testing | | | | | |
| 2.1 | Cytotoxicity | ISO 10993-5:2009 | Non-cytotoxic | Pass | |
| 2.2 | Delayed
hypersensitivity | ISO 10993-10:2010 | Non-Delayed
hypersensitivity | Pass | |
| 2.3 | Intradermal
reaction | ISO 10993-10:2010 | Non-Intradermal
reaction | Pass | |
| 2.4 | Acute systemic
toxicity | ISO 10993-11:2017 | Non-Acute systemic
toxicity | Pass | |
| 2.5 | Subchronic
systemic toxicity | ISO 10993-11:2017 | Non-Acute systemic
toxicity | Pass | |
| 2.6 | Genotoxicity | ISO 10993-3:2014 | Non-genotoxicity | Pass | |
Table VII-1: Performance testing was conducted on the subject device
10
11
VIII Clinical Test Conclusion
No clinical study is included in this submission.
IX Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the Dental porcelain powder is as safe and effective as the predicate device.