(327 days)
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No
The description focuses on the material composition and fabrication methods (hot press, CAD/CAM) of dental ceramic blocks, with no mention of AI or ML for analysis, processing, or decision-making.
No
The device, Dental Glass Ceramics Blocks, is a material used to fabricate dental restorations. It is not designed to treat or prevent a disease or condition directly; rather, it serves as a component in a restorative procedure.
No
The device, Dental Glass Ceramics Blocks, is used to fabricate dental restorations. Its intended use is for creating physical dental products, not for diagnosing medical conditions or diseases.
No
The device is a physical material (ceramic blocks) used to create dental restorations, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to create dental restorations (veneers, crowns, etc.) using hot press or CAD/CAM techniques. This is a manufacturing process for a medical device that will be placed in the patient's mouth.
- Device Description: The device is a material (ceramic blocks) used to fabricate dental prosthetics. It's a raw material for creating a medical device, not a diagnostic tool.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (blood, urine, tissue, etc.) or to provide information about a patient's health status or disease.
- Intended User/Care Setting: The intended user is a dental lab, which is where dental prosthetics are fabricated, not typically where diagnostic testing is performed.
IVD devices are specifically designed to perform tests on samples from the human body to provide diagnostic information. This device is a material used in the creation of a dental prosthetic, which is a different category of medical device.
N/A
Intended Use / Indications for Use
Dental Glass Ceramics Blocks are indicating all-ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior crowns, posterior crowns, using the hot press technique or CAD/CAM system.
Product codes
EIH
Device Description
Dental Glass Ceramics Blocks are derived from dental porcelain powder that has been processed into their final net shapes. These blanks are then being further fabricated (using hot press or CAD/CAM technologies) into all-ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior crowns, posterior crowns. The ceramics material is composed of SiO2, Li2O, Al2Os and other oxides. It also contains inorganic pigments to provide different shades on the product surface.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Bench testing was performed per ISO 6872:2015 and internal procedures to ensure that the Dental Glass Ceramics Blocks met its specifications. All tests were verified to meet acceptance criteria.
Biocompatibility testing was performed to verify the equivalent safety of the materials that are used. Clinical testing was not performed for the proposed device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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 & 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.
July 8, 2020
Aidite (Oinhuangdao) Technology Co., Ltd. % Christy Young Consultant Shenzhen Joyantech Consulting Co., Ltd NO. 55 Shizhou middle road , Nanshan District Shenzhen, Guangdong GD755, China
Re: K192231
Trade/Device Name: Dental Glass Ceramics Blocks Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: May 22, 2020 Received: June 8, 2020
Dear Christy Young:
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 (OS) 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 medical devices and radiation-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.
For Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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) K192231
Device Name Dental Glass Ceramics Blocks
Indications for Use (Describe)
Dental Glass Ceramics Blocks are indicating all-ceramic restorations such as veneers, inlay/ 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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Product: Dental Glass Ceramics Block
510(k) Summary
1. Contact Details
1.1 Applicant information
| Applicant Name | Aidite (Qinhuangdao) Technology Co., Ltd. |
|---|---|
| Address | No.9 Dushan Road,Economic and Technological Development Zone, |
| Qinhuangdao City China | |
| Phone No. | +86 335 8587898 |
| Fax No. | +86 335 8587198 |
| Contact person | Zhang Wei |
| Date Prepared | May 28, 2019 |
| Website | www.zro2blocks.com |
- 1.2 Submission Correspondent
| Shenzhen Joyantech Consulting Co., Ltd | |
|---|---|
| Room 1122, International Mayors Communication Centre, No. 55 Shizhou | |
| middle road , Nanshan District, Shenzhen | |
| 卓远天成 | |
| Phone No. | +86-755-86069197 |
| Contact person | Christy Young; Field Fu; |
| Contact person's e-mail | christy@cefda.com; cefda@foxmail.com |
| Website | http://www.cefda.com |
Device information 2.
.
| Trade name | Dental Glass Ceramics Blocks |
|---|---|
| Common name | Dental Glass Ceramics |
| Model | / |
| Classification | II |
| Classification name | Porcelain Powder for Clinical Use |
| Product code | EIH |
| Regulation No. | 872.6660 |
Legally Marketed Predicate Device 3.
| Trade Name | Dental Lithium Disilicate Glass Ceramic Block(Up.Press Series and Up.
CAD Series) |
|---------------|--------------------------------------------------------------------------------------|
| 510(k) Number | K141727 |
| Product Code | EIH |
| Manufacturer | Liaoning Upcera Co., Ltd |
4. Device Description
Dental Glass Ceramics Blocks are derived from dental porcelain powder that has been processed into their final net shapes. These blanks are then being further fabricated (using hot press or
4
CAD/CAM technologies) into all-ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior crowns, posterior crowns. The ceramics material is composed of SiO2, Li2O, Al2Os and other oxides. It also contains inorganic pigments to provide different shades on the product surface.
5. Intended Use/Indication for Use
Dental Glass Ceramics Blocks are indicating all-ceramic restorations such as veneers, inlay/onlay, partial crowns, anterior crowns, posterior crowns, using the hot press technique or CAD/CAM system.
| Item | Proposed Device:
Dental Glass Ceramics Blocks | Predicate Device:
Dental Lithium Disilicate
Glass Ceramic
Block(Up.Press Series and
Up. CAD Series)
(K141727) | Comments |
|----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Product Code | EIH | EIH | Same |
| Indications for
Use | 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. | Dental Lithium Disilicate Glass
Ceramic Blocks (Up. Press
Series and Up. CAD Series) are
indicated for fabricating
allceramic restorations such as
veneers, inlay/onlay, partial
crowns, anterior crowns,
posterior crowns, using the hot
press technique or CAD/CAM
system. | Same |
| Materials | SiO2, Li2O, K2O, Al2O3 and other
oxides | SiO2, Li2O, K2O, P2O5, Al2O3,
B2O3, and other oxides | Comparable(
Issue 1) |
| Processing at
Dental lab | Hot Press (Up. Press Series)
CAD/CAM (Up.CAD Series) | Hot Press (Up. Press Series)
CAD/CAM (Up.CAD Series) | Same |
| Geometry | Blocks | Blocks, disc and rod | Similar |
| Dimension | Various | Various | Same |
| Single use | Yes | Yes | Same |
| Available color | Various | Various | Same |
| Sterile | Non-sterile | Non-sterile | Same |
| Radioactivity
(Bq · g-1) | | | |
| Density(g/cm³) | Meet the requirements of ISO
6872:2015 | Meet the requirements of ISO
6872:2008 | Same |
| Flexural
Strength(MPa) | | | |
| Coefficient of
Thermal
Expansion (K-1) | | | |
| Glass Transition
Temperature (° C) | | | |
| Cytotoxicity (ISO
10993-5:2009) | No cytotoxicity effect | No cytotoxicity effect | Same |
| 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 | Same |
| Sensitization(ISO
10993-10:2010) | Not a sensitizer under the
conditions of the study | Not a sensitizer under the
conditions of the study | Same |
| Subacute and
Subchronic
Toxicity(ISO
10993-11:2006) | No subacute and subchronic
toxic effects observed | No subacute and subchronic
toxic effects observed | Same |
| Genotoxicity
( ISO10993-3:2003) | No genotoxic effects observed | No genotoxic effects observed | Same |
Substantial Equivalence Comparison 6.
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Product: Dental Glass Ceramics Block
lssue 1:
The subject device and the predicate devices might difference in compositions but all the devices have SiO2, Li2O, K2O and Al2O3 as major components. Despite this difference, the test results per ISO 6872 shows that the subject device is substantially equivalent to the predicate device in physical and chemical properties and meets the necessary requirements.
7. Non-clinical Testing
Bench testing was performed per ISO 6872:2015 and internal procedures to ensure that the Dental Glass Ceramics Blocks met its specifications. All tests were verified to meet acceptance criteria.
Biocompatibility testing was performed to verify the equivalent safety of the materials that are used.
8. Clinical testing
Clinical testing was not performed for the proposed device.
9. Conclusion
It has been shown in this 510(k) submission that Dental Glass Ceramics Blocks and its predicate devices have the similar indications for use, similar biocompatibility, and similar performance.
The difference between Dental Glass Ceramics Blocks and its predicate device do not raise any
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Product: Dental Glass Ceramics Block
question regarding its safety and effectiveness.
Dental Glass Ceramics Blocks, as designed and manufactured, is as safe and effective as its predicated device, and therefore is substantially equivalent as its predicate device.