XT stain/glaze are glazing porcelains used to color staining and glazing of the surfaces of dental ceramic restorations,such as glass ceramic or zirconia-based ceramic.

Device Description

XT stain/glaze includes glaze powder,glaze liquid,stain glaze,glaze spray. Glaze powder is composed primarily of SiO2,with components of B2O3,Al2O3, Na2O,K2O,Li2O, other oxides,and color additives. Glaze liquid is composed of deionized water and organic solvents. Stain glaze is mixed with glaze powder and glaze liquid,which can help dental professionals save the mixing process.It is in the form of a paste and applied to dental ceramic restoration surfaces by brushing.Glaze powder has 17 colors; therefore, glaze paste also has 17 colors. Glaze spray consists of glaze powder(Transparent-Glaze),organic solvent,deionized water, and Non-CFC propellant.It is supplied to dental professionals in the form of an aerosol can and applied to dental ceramic restoration surfaces by spraying. Glaze spray and stain glaze require the firing of the dental ceramic restorations after application of the glaze. During the firing process, the organic solvent and deionized water burn without being included in the dental ceramic restorations. Therefore, the final chemical composition of the dental ceramic restorations is the glaze powder.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for a dental product called "XT Stain/Glaze". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for showing an AI medical device meets specific performance criteria through a clinical study.

Therefore, the document does not contain the information requested regarding acceptance criteria for an AI-powered device, the specifics of a study proving such criteria are met, sample sizes for test/training sets, expert qualifications, or details of MRMC studies.

The document focuses on:

Device Description: XT Stain/Glaze is a dental material (porcelain powder, liquid, paste, spray) used for coloring, staining, and glazing dental ceramic restorations.
Substantial Equivalence: Comparing the subject device (XT Stain/Glaze) to predicate devices (K181167 and K202629) based on indications for use, form, application, composition, sterility, type of dental ceramic, packaging, shelf life, physical properties, and biocompatibility.
Non-Clinical Performance Data: Mentioning tests conducted like heavy metal testing (USP 43-NF 38:2020), other performance testing (ISO 6872), biocompatibility assessment (ISO 10993 series), transport and package testing (ISTA 3A), and shelf life evaluation (ASTM F1980).
No Clinical Performance Data: Explicitly states, "No data from human clinical studies has been included to support the substantial equivalence of the subject device, XT stain/glaze."

In summary, this document is a regulatory submission for a dental material, not an AI medical device. Thus, it does not provide the details required to answer your specific questions regarding AI device acceptance criteria and study data.

Summary

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Image /page/0/Picture/0 description: The image shows 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.

March 27, 2023

Shenzhen Xiangtong Co.,Ltd. Xue Gong Regulatory affairs 2nd Floor, 1st Building, West Area, Honghualing Industrial Park, No.88, North Zhuguang Rd Shenzhen, Guangdong 518055 CHINA

Re: K223192

Trade/Device Name: XT Stain/Glaze Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: December 27, 2022 Received: December 27, 2022

Dear Xue Gong:

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 (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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K223192

Device Name XT Stain/glaze

Indications for Use (Describe)

XT stain/glaze are glazing porcelains used to color staining and glazing of the surfaces of dental ceramic restorations,such as glass ceramic or zirconia-based ceramic.

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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Image /page/3/Picture/0 description: The image shows a logo with a stylized letter 'V' in blue. The 'V' is formed by a series of horizontal lines that converge at the bottom point. Above the 'V', there is a curved blue line that resembles a bird in flight or a wave. The overall design is simple and modern, using a consistent blue color scheme.

510(k) Summarv

Date of Summary Preparation: March 24, 2023

This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR Part 807.92.

The assigned 510(k) Number: K223192

1. Submitter's identifications

Submitter's name:SHENZHEN XIANGTONG CO.,LTD.

Address:2nd Floor, 1st Building, West Area, Honghualing Industrial Park, No.88, North Zhuguang Rd, Nanshan District, Shenzhen, 518055, China.

Tel: +86-0755-86001801 Email: xtcera@xianton.com Website:en.xtcera.com

2. Correspondent's identifications

Contact person:Xue Gong

Title:Regulatory supervisor

Tel: +86-13760477635 - Email:gongx(@xianton.com/1315337087(@gq.com

Or,

Other contact person:Rose

Tel: +86-15989372253 Email:Rose@xianton.com

3. Device information

Type of 510(k) submission: Traditional

Device common name: Dental porcelain/ceramic

Device Name/Proprietary Name/Trade Name:XT stain/glaze

Classification Name: Porcelain powder for clinical use

Classification Regulation: 21 CFR 872.6660

Class: Class 2

Panel: Dental

Product code: EIH

4. Legally marketed predicate device

Primary Predicate device: K181167, "Glaze Paste, Glaze Powder, and Glaze Liquid", manufactured by "Liaoning Upcera Co., Ltd."

Reference device:

K202629, "Dentsply Sirona Universal Spray Glazes", manufactured by "Dentsply Sirona"

Reference device support the substantial equivalence of the glaze spray in the subject device.

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Image /page/4/Picture/0 description: The image shows a logo with a stylized letter 'V' in blue, composed of horizontal lines that create a gradient effect. Above the 'V' are two curved, blue shapes resembling wings or waves, positioned to suggest movement or flight. The logo has a clean and modern design, likely representing a company or organization with a name starting with 'V'.

5. Device description

XT stain/glaze includes glaze powder,glaze liquid,stain glaze,glaze spray. Glaze powder is composed primarily of SiO2,with components of B2O3,Al2O3,

Na2O,K2O,Li2O, other oxides,and color additives.

Glaze liquid is composed of deionized water and organic solvents.

Stain glaze is mixed with glaze powder and glaze liquid,which can help dental professionals save the mixing process.It is in the form of a paste and applied to dental ceramic restoration surfaces by brushing.Glaze powder has 17 colors; therefore, glaze paste also has 17 colors.

Glaze spray consists of glaze powder(Transparent-Glaze),organic solvent,deionized water, and Non-CFC propellant.It is supplied to dental professionals in the form of an aerosol can and applied to dental ceramic restoration surfaces by spraying.

Glaze spray and stain glaze require the firing of the dental ceramic restorations after application of the glaze. During the firing process, the organic solvent and deionized water burn without being included in the dental ceramic restorations. Therefore, the final chemical composition of the dental ceramic restorations is the glaze powder.

6. Indications for use

XT stain/glaze are glazing porcelains used to color staining and glazing of the surfaces of dental ceramic restorations.such as glass ceramic or zirconia-based ceramic.

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Image /page/5/Picture/0 description: The image shows a logo with a stylized letter "V" formed by horizontal lines in shades of blue. Above the "V", there is a blue, wave-like shape that resembles a bird in flight. The logo is simple and modern, using color and shape to create a recognizable symbol.

7. Substantial equivalence comparison

Description	Subject device(K223192)	Predicate device(K181167)	Reference device(K202629)	Comment
Manufacturer	SHENZHEN XIANGTONGCO.,LTD.	Liaoning Upcera Co., Ltd.	Dentsply Sirona	None
Proprietaryname	XT stain/glaze	Glaze Paste, Glaze Powder,and Glaze Liquid	Dentsply Sirona Universal SprayGlazes	None
Product code	EIH	EIH	EIH	Same
Regulationnumber	21 CFR 872.6660	21 CFR 872.6660	21 CFR 872.6660	Same
Classification	Class 2	Class 2	Class 2	Same
Indication foruse	XT stain/glaze are glazingporcelains used to colorstaining and glazing of thesurfaces of dental ceramicrestorations,such as glassceramic or zirconia-basedceramic.	"Glaze Paste, Glaze Powder,and Glaze Liquid" areindicated for use as aveneering material for fixedprosthesis in crowns andbridges. This device is usedin prosthetic dentistry byforming a porcelain veneeron to a ceramic substructure.	Dentsply Sirona Universal SprayGlazes are aerosol glazingporcelains used to glaze highstrength glass ceramic andzirconia dental restorations. Theglaze sprays are applied torestorations and fired.	SameSee 7(1) forexplanatory notes

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Image /page/6/Picture/0 description: The image shows a logo with a stylized letter 'V' formed by a series of horizontal lines that decrease in length from top to bottom, creating a triangular shape. The lines are in varying shades of blue, with the top lines being darker and gradually lightening towards the bottom. Above the 'V' is a curved, light blue shape resembling a bird in flight or a wave, adding a sense of movement and openness to the design.

Form	Paste, spray, liquid, and powder	Paste, liquid, and powder	Spray	Similar to reference deviceSee 7(2) for explanatory notes	Single Use	Yes	Yes	Yes	Same
Application	Brushing, spraying	Brushing	The glaze is applied by spraying on to the surface of the dental restorations and a firing process is carried out in a dental furnace.	Similar to reference deviceSee 7(2) for explanatory notes	Feature	Various colors	Various colors	Various colors	Same
Composition	SiO2,B2O3,Al2O3,Na2O,K2O,Li2O, etcGlaze spray contains organic solvent, deionized water, and Non-CFC propellent that is burned off during the firing process and is not included in the dental ceramic restorations.	SiO2, Al2O3, K2O, Na2O,Li2O, etc	Major components:oxides(silicate glass)Device contains organic components and propellent that is burned-off during the firing process and is not included in the final device.	SimilarSee 7(3) for explanatory notes	Sterile	Non-sterile	Non-sterile	Non-sterile	Same
Type, class of dental ceramic	Type I - Class I	Type I - Class I	Type I - Class I	Same	Packagingcomponents	Plastic bottle, aerosol canwith propellent	Not publicly available	Packaged in a spray can withcap	DifferentSee 7(4) forexplanatory notes
Use	Prescription	Prescription	Prescription	Same	Shelf life/Storage	3 yearsThe packaged product shallbe stored in a room wherethere is good ventilation,avoid strong sunlight, andwithout corrosivegas, temperature not morethan 45°C .Keep thepackage intact and upwardduring storage.	Not publicly available	3.5 yearsAvoid exposure to temperaturesexceeding 50°C / 122 °F.	DifferentSee 7(5) forexplanatory notes
Physicalproperties	Meet the requirements ofISO 6872,USP43-NF38:20201.Uniformity2.Freedom of extraneousmaterials	Meet the requirements ofISO 68721.Flexural strength2.Transition temperature6.Thermal expansion4.Radadiopacity	Meet the requirements of ISO68721.Uniformity2.Freedom of extraneousmaterials3.Flexural strength	SimilarThe performance ofthe subject deviceincludes predicatedevice and referencedevice.

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Image /page/7/Picture/0 description: The image shows a logo with a stylized letter 'V' in purple, composed of horizontal lines that create a sense of depth. Above the 'V' is a blue, curved shape resembling a bird in flight or a wave, adding a dynamic element to the design. The logo appears clean and modern, with a focus on simplicity and visual appeal.

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Image /page/8/Picture/0 description: The image shows a logo with a stylized letter 'V' in blue and purple. The 'V' is formed by a series of horizontal lines that decrease in length from top to bottom, creating a layered effect. Above the 'V', there is a curved, wave-like shape in a lighter shade of blue, resembling a bird in flight or a stylized wave. The overall design is simple and modern, with a focus on geometric shapes and a limited color palette.

	3.Mixing and condensation4.Flexural strength5.Chemical solubility6.Linear thermal expansioncoefficient7.Radiopacity8.Glass transitiontemperature9.Heavy metal		4.Chemical solubility5.Linear thermal expansioncoefficient6.Radiopacity7.Glass transition temperature
Biocom-patibility	Meet the requirements ofISO 10993-1,-3,-5,-10,-11	Meet the requirements ofISO 10993-1,-3,-5,-10,-11	Conform to ISO 7405 and ISO10993-1,-5	SimilarWe performed ISO10993 test to proveour product'sbiocompatibility.

Notes:

(1)Indication for use

Subject device and predicate device:

a. The main role of the veneering material is color staining and glazing porcelains belong to veneering material.

b.Prosthesis and restorations are only descriptive differences.

c.Glass ceramic and zirconia-based ceramic belong to ceramic substructure.

The subject device XT stain/glaze and the predicate device have the same use, XT stain/glaze is worded differently for simplification.

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Image /page/9/Picture/0 description: The image shows a logo with a stylized letter 'V' in blue, composed of horizontal lines that create a sense of depth or perspective. Above the 'V', there is a curved, wave-like shape, also in blue, that resembles a bird in flight or a stylized wave. The overall design is simple and modern, suggesting a connection to water, aviation, or a sense of forward movement.

Compared with the predicate device, the subject device has a slightly different phrasing of potential dental applications in the Indications for Use Statement. This difference in wording is minor, and the subject device with the recommended clinical indications in Table 1 of ISO 6872: 2015.

The subject device and reference device have use and only the wording differs. Reference device is only one type of spray glaze form.

(2)Form

For restorations that don't require color finishing, brushing stain glaze (color:Transparent-Glaze) or spray (color:Transparent-Glaze) directly.

Paste and sprays are designed according to usage habits. The glaze spray in an aerosol form decreases the in-process time of hand-applied glazing methods and for ease of use in dental laboratories.

(3)Composition

The final chemical composition of the dental ceramic restorations is the glaze powder.

Subject device( glaze powder,glaze) and predicate device(Glaze Paste, Glaze Powder, and Glaze Liquid):

The subject and predicate device have slight difference in composition. But they silicate glass and oxides as the major component. The minor differences don't raise any additional questions for safety and effectiveness. And the biocompatibility testing of the overall proposed device passed.

Subject device(glaze spray) and reference device(Dentsply Sirona Universal Spray Glazes):

Both devices consist of refined aerosol delivery systems used to apply the same working principle in that the glaze is applied by a spray jet onto the restoration and a firing process is carried out to melt the glaze. Both devicess use Non-CFC propellants to eject the contents.

The main composition of both devices are similar. The silicate glass,organic solvent, wetting agents(deionized water), and Non-CFC propellent are similar.The final device contains only silicates, the other components burned off during process.

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Image /page/10/Picture/0 description: The image shows a logo with a stylized bird flying above a geometric shape. The bird is blue and appears to be in flight, with its wings spread. Below the bird is a purple, V-shaped figure composed of horizontal lines that converge at the bottom. The logo has a clean and modern design.

(4)Packaging components

The packaging of glaze spray is the same as the reference device. Transport and package testing were performed on plastic bottle and aerosol can according to ISTA 3A and the standards referenced therein.

(5)Shelf life/ Storage

Evaluation of shelf life per ASTM F1980.Storage conditions for subject device within the range of reference device.

The subject device and the predicate devices have indication for use, biocompatibility properties, and similar design, material, physical, and chemical properties. The non-clinical test results show that the minor differences dout safety and effectiveness.

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Image /page/11/Picture/0 description: The image shows a logo with a stylized bird in blue above a purple "V" shape. The bird is formed by a curved line, and the "V" is made up of several horizontal lines. The logo is simple and modern, using a limited color palette.

Non-Clinical performance data 8.

Test data to support the evaluation of the subject device XT stain/glaze have been submitted and included by reference as follows:

Product heavy metal testing per USP 43-NF 38:2020<233> ,other performance . testing per ISO 6872, Dentistry - Ceramic materials.

. Biocompatibility assessment as follows:

& Evaluation per ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.

� Genotoxicity assessment per ISO 10993-3, Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.

◆ Cytotoxicity assessment per ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.

& Sensitization and irritation assessment per ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

& Toxicity assessment per ISO 10993-11, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.

. Transport and package testing per ISTA 3A and the standards referenced therein.
Evaluation of shelf life per ASTM F1980, Standard Guide for Accelerated Aging of . Sterile Barrier Systems for Medical Devices.

9. Clinical performance data

No data from human clinical studies has been included to support the substantial equivalence of the subject device, XT stain/glaze.

10. Substantial equivalence conclusion

The subject device XT stain/glaze and the predicate device "Glaze Paste, Glaze Powder, and Glaze Liquid" have the same indication for use as glazing materials, incorporate the same fundamental techniques, and have similar significant components.

Both the predicate and subject devices have similar technological characteristics and were tested to the same ISO 6872:2015 (Dentistry-Ceramic materials) standard and met the same specification requirements of Type I Class 1 materials.

The difference between the subject device and its predicate device do not raise any question regarding its equivalence.

The comparative information, combined with the design and intended use comparison with the predicate device, support substantial equivalence to the subject device XT stain/glaze.

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.