(144 days)
Not Found
No
The summary describes a dental material (glass ceramic) and its physical and biocompatibility testing. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No.
The dental glass ceramics described are materials used for fabricating dental restorations (veneers, crowns, etc.), not a device that directly treats or prevents disease. Its purpose is to replace or restore tooth structure.
No
This device is a dental glass ceramic material used for manufacturing dental prosthetics (veneers, crowns, etc.), not for diagnosing medical conditions.
No
The device description clearly states it is composed of various chemical compounds, indicating it is a physical material (dental glass ceramics) used for fabrication, not software. The performance studies also focus on physical and biocompatibility testing of this material.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for fabricating dental restorations (veneers, crowns, etc.) using hot press or CAD/CAM techniques. This is a manufacturing process for a medical device that will be implanted or placed in the body, not a test performed on a biological sample to diagnose a condition.
- Device Description: The description lists the chemical composition of the ceramic material. This is typical for a material used in manufacturing, not for a reagent or kit used in an in vitro test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The performance studies focus on the physical and biocompatibility properties of the material itself, not on its ability to perform a diagnostic test.
- Anatomical Site: The anatomical site is the human denture or tooth restoration, which is where the fabricated device will be placed, not where a biological sample would be collected for an IVD test.
In summary, this device is a material used to manufacture dental prosthetics, which are medical devices, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Dental Glass Ceramics are indicated for fabrications such as veneers, inlay/ onlay/ onlay/ partial crowns, anterior crowns, posterior crowns, using the hot press technique or CAD/CAM system.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
This product is composed of SiO2 , Al2O3 , Li2O , K2O , Na2O , CeO2 , Pr6O11 , ZrO2 , P2O5 , СаО , МпО2 , Ег2Оз .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human denture or tooth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professional dentists in legal and formal custom denture manufacturing facilities.
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 Glass Ceramics was performed to demonstrate verification testing in conformance with the acceptance criteria of test methods and recognized consensus standards shown below.
ID# 1: Physical Testing of Dental Glass Ceramics
Test: Material composition content
Method: Ingredient Content (%)
Acceptance Criteria: Product technical requirements
Test result: Silicon dioxide (SiO2): 68.32%, Alumina (Al2O3) : 4.02%, Lithium oxide (Li2O): 13.09%, Potassium oxide + sodium oxide (K2O+Na2O): 3.02%, Phosphorus pentoxide(P2O5): 3.53%, Zirconium (hafnium) dioxide (Zr (Hf) O2 ): 1.86%, Praseodymium oxide (Pr6O11): 1.66%, Cerium dioxide (CeO2): 1.61%, Erbium oxide(Er2O3): 1.59%, Manganese dioxide (MnO2):
§ 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.
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Image /page/0/Picture/0 description: The image contains 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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
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: K232673
Trade/Device Name: Dental Glass Ceramics 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.
1
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" (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 QS 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).
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Sincerely,
Michael E. Adjodha -S
Michael E. Adjodha, MChE, RAC, CQIA 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) K232673
Device Name Dental Glass Ceramics
Indications for Use (Describe)
Dental Glass Ceramics are indicated for fabrications such as veneers, inlay/ onlay/ onlay/ partial crowns, anterior crowns, posterior crowns, using the hot press technique or CAD/CAM system.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary — K232673
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 Glass Ceramics |
|---|---|
| Regulation Number: | 21 CFR 872.6660 |
| Classification Name: | Powder, Porcelain |
| Product Code: | EIH |
| Regulatory Class | II |
| Review Panel | Dental |
III Predicate Devices
| 510k Number | K141727 | Device
Characteristic | Subject Device | Predicate Device
(K141727) | Discussion |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|-------------------------------------------------------------------------------------------|------------|
| Trade Name of Device: | Dental lithium disilicate glass ceramic block (up. Press series
and up. Cad series) | Trade name | Dental Glass Ceramics | Dental lithium disilicate glass
ceramic block (up. Press series
and up. Cad series) | N/A |
| Regulation Number: | 21 CFR 872.6660 | Product code | EIH | EIH | Identical |
| Classification Name: | Powder, Porcelain | Regulation
Number | 21 CFR 872.6660 | 21 CFR 872.6660 | Identical |
| Regulatory Class | II | Regulatory
class | Class II | Class II | Identical |
| Product Code: | EIH | Manufacturer | Chengdu Besmile Medical
Technology Co., Ltd. | Liaoning Upcera Co., Ltd. | N/A |
| Intended Use | Dental Glass Ceramics 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. | Dental Lithium Disilicate Glass
Ceramic Blocks (Up. Press Series
and Up. CAD Series) 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. | Identical | | |
| Structure
Composition | SiO2 , Al2O3 , Li2O , K2O , Na2O ,
CeO2 , Pr6O11 , Zr(Hf)O2 , P2O5 ,
CaO , MnO2 , Er2O3. | SiO2, Li2O, K2O, P2O5, Al2O3, B2O3,
and other oxides | Different
Comment 1 | | |
| Physical Form | Solid | Solid | Identical | | |
| Operation
Principle | This product is suitable for
CAD/CAM and die casting, and is
suitable for various grinding and
polishing equipment.
(1) CAD/CAM production
process:
① Digitally scan models,
wax-ups or oral preparations to
obtain 3D data sets;
② Software processing of 3D
data sets to design restorations;
③ Computer-controlled
machining tools complete the
fabrication (prosthesis) process; | This product is a material for
making all porcelain dentures, and
the method of computer aided
design/computer aided
manufacturing is used to make all
porcelain dentures. Use the
process to obtain dental module
data for scanning -CAD design
denture machining model -CAD
fabrication denture - denture
sintering and glazing - denture
finished product. | Different
Comment 2 | | |
IV Device Description
This product is composed of SiO2 , Al2O3 , Li2O , K2O , Na2O , CeO2 , Pr6O11 , ZrO2 , P2O5 , СаО , МпО2 , Ег2Оз .
V Indications for use
Dental Glass Ceramics 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.
VI Technological Characteristics Comparison
VI-1: Comparison of Dental Glass Ceramics
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| Device
Characteristic | Subject Device | Predicate Device
(K141727) | Discussion |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| | ④ After 30min secondary
crystallization treatment at
800°C-840°C, the finished product
is made by professional
technicians, and finally used by
professional doctors for human
denture or tooth restoration.
(2) Die-casting production
process:
① Use CAD/CAM
computer-aided design to
process wax-up restorations;
② Embed the wax-up restoration
with embedding material;
③ Put the embedding ring into
the muffle furnace and heat it to
completely evaporate the
wax-type restoration;
④ Put the embedding ring into
the die-casting furnace, put it into
the ceramic block for die-casting,
the die-casting temperature is
930°C-960°C, and the time is
10min;
⑤ After the die-casting is cooled,
use sandblasting tools to clean
the embedded materials on the
surface of the restoration, and
then make the finished product
by professional technicians, and
finally use it for human dentures
or tooth restoration by
professional doctors.
⑥ This product is recommended
to use dental casting ceramic
quick embedding material, which
is suitable for all die casting
furnaces and sandblasting tools
on the market. | | |
| Device
Characteristic | Subject Device | Predicate Device
(K141727) | Discussion |
| Device design | The product design is cylinder
and cuboid. | The product design is cylinder and
cuboid. | Identical |
| size | Cylinder
(Diameter × Height) mm:
12.5×11, 12.5×13, 12.5×15,
12.5×17, 11×8, 16×16, 98×10,
98×14, 98×18, 98×22, 95×14,
95×22, 100×12, 12×18, 20×20,
98×12, 98×16, 98×20, 98×25,
95×18, 100×10, 100×14
Cuboid
(Length × Width × Height) mm:
14×12×10, 15.5×13×11,
18.5×14.9×12.5, 18.5×16.9×12.5,
18.5×17.9×12.5, 72×44×42,
72×42×20, 72×42×18,
72×42×16, 72×42×14,
72×42×12, 93×75×16,
87×56×16, 75×38×16, 43×25×16, 58×29×16 | Cylinder
(Diameter × Height) mm:
13×10
Cuboid
(Length × Width × Height) mm:
18×15×13, 40×15×15 | Different
Comment 3 |
| Sterility | Non-sterile | Non-sterile | Identical |
| Materials | Lithium disilicate glass ceramics
Porcelain block density: ≥ 2.2g
/cm³. | Lithium disilicate glass ceramics
The density of the porcelain block
can be processed :2.3 ~ 2.6g/cm³. | Identical |
| Physicochemic
al properties | Flexural strength: The average
flexural strength of 10 samples
after sintering should be ≥300
MPa | The density of processed porcelain
after sintering :2.4 ~ 2.7g/cm³.
The biaxial bending strength of the
processed porcelain block after | Different
Comment 4 |
| Device
Characteristic | Subject Device | Predicate Device
(K141727) | Discussion |
| | Chemical solubility: After final
sintering should be