Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

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.

Therapeutic

No
The device is a dental material used to fabricate restorations like veneers and crowns, which is a structural component and not a device that directly treats or prevents a disease or condition.

Diagnostic

No

The device description indicates that the Dental Glass Ceramics Blocks are for fabricating all-ceramic restorations and are composed of various oxides and pigments. The "Intended Use" also describes their use in creating restorations. There is no mention of the device being used to diagnose a medical condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical product (blocks of ceramic material) used to fabricate dental restorations. It is not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Description and Intended Use: The description clearly states that the Dental Glass Ceramics Blocks are used to fabricate dental restorations (veneers, crowns, etc.) that are placed in the mouth. They are a material used for creating a physical structure, not for analyzing biological samples.
Lack of IVD Characteristics: The document does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes.

Therefore, the Dental Glass Ceramics Blocks are a dental material used for restorative purposes, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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, K2O, Al2O3 and other oxides. It also contains inorganic pigments to provide different shades on the product surface.

The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials.

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

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. Test results on radioactivity, dimension, flexural strength, chemical solubility, linear thermal expansion coefficient, freedom from extraneous materials, uniformity, glass transition temperature, sintering density and fracture toughness of the subject device are very similar to predicate device. Biocompatibility testing was performed to verify the equivalent safety of the materials that are used.

According to ISO 10993-1:2018, we evaluated and conducted the compatibility test for the proposed device.

No clinical study is included in this submission.

Key Metrics

Not Found

Predicate Device(s)

K192231

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 1, 2023

Aibodent Biotechnology Co., Ltd % Shanfeng Jiang Regulation Control Manager Guangzhou Junyi Information Technology Co., Ltd. Room 304, Building A. No. 62 Nanyun 2nd Road, Science Town Huangpu District, Guangzhou City, Guangdong 510663 CHINA

Re: K232438

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: November 3, 2023 Received: November 3, 2023

Dear Shanfeng Jiang:

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.

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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).

2

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K232438

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)

× Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Section 5 - 510(k) Summary

K232438 Date of Summary Preparation: August 14, 2023 Date of Modification: November 29, 2023

1. Submitter's Identifications

Submitter's Name: Aibodent Biotechnology Co., Ltd 1. Address: No.201, 3rd building of Hai Ping Medical Device Area, Changsha, China. Zip Code: 410205 Contact Person: Qingliang Chen Contact Title: General Manager Contact E-mail Address: 1141076406@gq.com Tel: +86-731-88995948

2. Correspondent's Identifications

Correspondent's Name: Guangzhou Junyi Information Technology Co., Ltd. Address: Room 304, Building A, No. 62 Nanyun 2nd Road, Science Town, Huangpu District, Guangzhou City, Guangdong, 510663, China ZIP Code: 510663 Contact Person: Shanfeng Jiang Contact Title: Regulation Control Manager Contact E-mail Address: jiang13620586569@126.com Tel: +86-20-82329549 Fax: +86-20-82329549

3. Name of the Device

Device Classification Name: Powder, Porcelain Regulation Description: Porcelain powder for clinical use Trade Name: Dental Glass Ceramics Blocks Model: HT, LT Regulation Medical Specialty: Dental Review Panel: Dental Product Code: EIH Regulation Number: 21 CFR 872.6660 Device Classification: Class II

4. The Predicate Devices

Predicate device: K192231 Dental Glass Ceramics Blocks Aidite (Qinhuangdao) Technology Co., Ltd.

5. Device Description

5

Aibodent Biotechnology Co., Ltd

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, K2O, Al2O3 and other oxides. It also contains inorganic pigments to provide different shades on the product surface.

The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials.

6. 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.

7. Summary of Substantial Equivalence

	Proposed Device	Predicate device	Comparison
510k Number		K192231	------
Product Code	EIH	EIH	Same
Proprietary Name	Dental
Glass
Ceramics Blocks	Dental
Glass
Ceramics Blocks	------
Model:	HT, LT	------	------
Manufacturer	Aibodent
Biotechnology Co.,
Ltd	Aidite
(Qinhuangdao)
Technology Co.,
Ltd.	------
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	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	Same
	CAD/CAM
or	CAD/CAM
or
	system.	system.
Materials	SiO2, Li2O, K2O,
Al2O3 and other
oxides.	SiO2, Li2O, K2O,
Al2O3 and other
oxides.	Same
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	Same
Dimension	Various	Various	Same
Single Use	Yes	Yes	Same
Available color	Various	Various	Same
Sterile	Non-sterile	Non-sterile	Same
Radioactivity
(Bq.g-1)	Meet
the
requirements
of
ISO6872:2015	Meet
the
requirements
of
ISO6872:2015	Same
Density(g/cm3)	Meet
the
requirements
of
ISO6872:2015	Meet
the
requirements
of
ISO6872:2015	Same
Flexural
Strength(MPa)	Meet
the
requirements
of
ISO6872:2015	Meet
the
requirements
of
ISO6872:2015	Same
Coefficient of
Thermal
Expansion (K-1)	Meet
the
requirements
of
ISO6872:2015	Meet
the
requirements
of
ISO6872:2015	Same
Glass Transition
Temperature(°C)	Meet
the
requirements
of
ISO6872:2015	Meet
the
requirements
of
ISO6872:2015	Same
Cytotoxicity
(ISO10993-5:2009
)	No
cytotoxicity
effect	No
cytotoxicity
effect	Same
Irritation Oral
Mucosa
Irritation(ISO109
93-10:2010)	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
10993-10:2021)	Not a sensitizer
under the
conditions of the
study	Not a sensitizer
under the
conditions of the
study	Same
Subacute and
Subchronic
Toxicity(ISO1099
3-11:2006)	No subacute and
subchronic
toxic effects
observed	No subacute and
subchronic
toxic effects
observed	Same
Genotoxicity
( ISO10993-3:200

```
                   | No genotoxic
```

effects observed | No genotoxic
effects observed | Same |
| Discussion for
Substantially
Equivalent (SE) | The proposed device is essentially identical to the predicate devices in terms of indication for use, design between our device and the predicate devices. | | |

Table 1 Comparison to Predicate Device

6

Aibodent Biotechnology Co., Ltd

7

Aibodent Biotechnology Co., Ltd

The proposed device is essentially identical to the predicate devices in terms of indication for use, design between our device and the predicate devices.

8. Summary of 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. Test results on radioactivity, dimension, flexural strength, chemical solubility, linear thermal expansion coefficient, freedom from extraneous materials, uniformity, glass transition temperature, sintering density and fracture toughness of the subject device are very similar to predicate device. Biocompatibility testing was performed to verify the equivalent safety of the materials that are used.

According to ISO 10993-1:2018, we evaluated and conducted the compatibility test for the proposed device.

9. Clinical Test Conclusion

No clinical study is included in this submission.

10. Conclusion:

The conclusions drawn from the nonclinical tests demonstrate that subject device Dental Glass Ceramics Blocks performs as well as or better than the legally marketed predicate device K192231 Dental Glass Ceramics Blocks. Dental Glass Ceramics Blocks is substantial equivalent to the legally marketed predicate device K192231 Dental Glass Ceramics Blocks.