Pre-Sintered Zirconia Coloring Liquid is mainly divided into 16 colors, 26 colors and special colors. The product is mainly composed of purified water(55%~~95%), ferric chloride (0~~9%), Erbium Chloride(0~17%), polyethylene glycol(2%~6%),Polydextrose(0.5%~8%),Gluconic acid(1%~2%),Citric acid(0%~~1%) and Yttrium chloride(0~~12%).

AI/ML Overview

The document describes the Pre-Sintered Zirconia Coloring Liquid and its non-clinical testing for safety and performance.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Physical Testing of Pre-Sintered Zirconia Coloring Liquid
Specification: Product technical requirements	Pass
Appearance: Homogeneous and impurity-free liquid	Pass
Post-dyeing comparison requirements: No significant difference in color between dental specimens and VITA veneer colorimeter or standard dental specimens	Pass
Heavy metal content: Less than 10 mg/L (in Pb)	Pass
Biocompatibility Testing
Cytotoxicity (ISO 10993-5:2009): Non-cytotoxic	Pass
Delayed hypersensitivity (ISO 10993-10:2010): Non-Delayed hypersensitivity	Pass
Intradermal reaction (ISO 10993-10:2010): Non-Intradermal reaction	Pass
Acute systemic toxicity (ISO 10993-11:2017): Non-Acute systemic toxicity	Pass
Subchronic systemic toxicity (ISO 10993-11:2017): Non-Subchronic systemic toxicity	Pass

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample size used for each physical and biocompatibility test. It mentions "dental specimens" for the post-dyeing comparison and implies testing on samples for heavy metal content, cytotoxicity, hypersensitivity, intradermal reaction, and systemic toxicity. The provenance of the data is not explicitly stated beyond being "non-clinical testing" conducted on the subject device. It is assumed to be internal testing by Chengdu Besmile Medical Technology Co., Ltd.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not mention the involvement of experts for establishing ground truth in the non-clinical tests described. The "ground truth" for these tests would be defined by the standardized methodologies (e.g., ISO standards for biocompatibility, instrumental measurements for heavy metals, visual comparison against color guides for post-dyeing).

4. Adjudication method for the test set

Not applicable for these types of non-clinical tests. The tests rely on objective measurements and adherence to specified standards rather than expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a pre-sintered zirconia coloring liquid, not an AI-powered diagnostic device, so MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a material product, not a software algorithm.

7. The type of ground truth used

Physical Testing: Ground truth is established by:
- Specification: Product technical requirements.
- Appearance: Visual inspection against established criteria (homogeneous and impurity-free).
- Post-dyeing comparison: Comparison against VITA veneer colorimeter or standard dental specimens.
- Heavy metal content: Analytical measurement against a specified threshold (less than 10 mg/L in Pb).
Biocompatibility Testing: Ground truth is established by adherence to the criteria defined in the specific ISO standards (e.g., ISO 10993-5, ISO 10993-10, ISO 10993-11) for non-cytotoxicity, non-hypersensitivity, non-intradermal reaction, and non-systemic toxicity.

8. The sample size for the training set

Not applicable. This device is a material product, not an AI model that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as no training set is relevant for this device.

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). 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

March 19, 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: K232682

Trade/Device Name: Pre-Sintered Zirconia Coloring Liquid 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: December 20, 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.

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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).

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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) K232682

Device Name Pre-Sintered Zirconia Coloring Liquid

Indications for Use (Describe)

It is only used for coloring Zirconia Dental Ceramics of our company to achieve clinical aesthetic restoration.

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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Section 3 510(k) Summary

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: 86-28-85317108
	E-mail: 79802494@qq.com

II Device

Trade Name of Device:	Pre-Sintered Zirconia Coloring Liquid
Regulation Number:	21 CFR 872.6660
Classification Name:	Powder, Porcelain
Product Code:	EIH
Regulatory Class	II
Review Panel	Dental

III Predicate Devices

510k Number	K141723 (Primary predicate)
Trade Name of Device:	Upcera Coloring Liquid (I and II)
Regulation Number:	21 CFR 872.6660
Regulation Name:	Powder, Porcelain
Regulatory Class	II
Product Code:	EIH

IV Device Description

Pre-Sintered Zirconia Coloring Liquid is mainly divided into 16 colors, 26 colors and special colors.

The product is mainly composed of purified water(55%~~95%), ferric chloride (0~~9%), Erbium Chloride(0~17%), polyethylene glycol(2%~6%),Polydextrose(0.5%~8%),Gluconic acid(1%~2%),Citric acid(0%~~1%) and Yttrium chloride(0~~12%).

V Indications for use

It is only used for coloring Zirconia Dental Ceramics of our company to achieve clinical aesthetic restoration.

VI Technological Characteristics Comparison

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DeviceCharacteristic	Subject Device	Predicate Device(K141723)	Discussion
Trade name	Pre-Sintered Zirconia ColoringLiquid	Upcera Coloring Liquid (I and II)	N/A
Product code	EIH	EIH	Identical
RegulationNumber	21 CFR 872.6660	21 CFR 872.6660	Identical
Regulatoryclass	Class II	Class II	Identical
Manufacturer	Chengdu Besmile MedicalTechnology Co., Ltd.	Liaoning Upcera Co., Ltd.	N/A
Intended Use	It is only used for coloringZirconia Dental Ceramics of ourcompany to achieve clinicalaesthetic restoration.	Upcera Coloring Liquid (I and II)is a liquid used for the completeor partial coloration of milledUpcera zirconia substructure andanatomy before sintering.	SimilarComment1
StructureComposition	The product is mainly composedof purified water(55%~~95%),ferric chloride (0~~9%), ErbiumChloride(0~17%), polyethyleneglycol(2%~6%),Polydextrose(0.5%~8%),Gluconic acid(1%~2%),Citricacid(0%~~1%) and Yttriumchloride(0~~12%).	Water, polyethylene glycol, HCI,inorganic salts.	SimilarComment 2
Physical Form	Liquid	Liquid	Identical
OperationPrinciple	Immersion method:1) Shake the coloring liquid wellbefore dyeing. Choose theappropriate container and pour inthe appropriate amount ofcoloring liquid.2) Zirconia was lightly put intocoloring liquid with plastictweezers and soaked for 10seconds.	Brush or immerse zirconia dentalceramics with coloring liquidbefore sintering.	SimilarComment3
DeviceCharacteristic	Subject Device	Predicate Device(K141723)	Discussion
	30-60 minutes (it is
	recommended to use infrared
	lamp or oven and place it in the
	position of 8-100mm under
	infrared lamp or at 80-90 °C of
	oven).
	4) The dyed zirconia was
	compared with VITA*16 color
	system, VITA*26 color system
	and Special colors (01, 02, 03,
	G1, G2, G3, P1, P2, P3, V1, V2,
	V3, TO1, TO2, TO3, TO4, BL1,
	BL2,BL3, BL4, 0M1, 0M2,0M3).
	Brushing method:
	1) Shake the coloring liquid well
	before dyeing. Choose the
	appropriate container and pour in
	the appropriate amount of
	coloring liquid.
	2) Zirconia was dipped in coloring
	liquid with a ceramic pen and
	brushed 1-2 times.
	3) Zirconia is dried for 30-60
	minutes (it is recommended to
	use infrared lamp or oven and
	place it in the position of
	8-100mm under infrared lamp or
	at the temperature of 80-90 °C in
	the oven).
	4) The dyed zirconia was
	compared with VITA*16 color
	system, VITA*26 color system
	and Special colors (01, 02, 03,
	G1, G2, G3, P1, P2, P3, V1, V2,
	V3, TO1, TO2, TO3, TO4, BL1,
	BL2,BL3, BL4, 0M1, 0M2,0M3).
DeviceCharacteristic	Subject Device	Predicate Device(K141723)	Discussion
	BL2, BL3, BL4, 0M1, 0M2, 0M3).
Bottle Size	Various	Various	Identical
Type ofPackaging	Liquid container	Liquid container	Identical
Color	Various	Various	Identical
PrescriptionUse	Prescription only	Prescription only	Identical
Sterility	Non-sterile	Non-sterile	Identical

VI-1: Comparison of Pre-Sintered Zirconia Coloring Liquid

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Comment 1

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.And both have exactly the same intended use: as a zirconia dental ceramic colorant.

Comment 2

There are some minor differences between Pre-Sintered Zirconia Coloring Liquid and the predicate device. First, the predicate device contains HCI. HCI will be evaporated with no residue left at the sintering step after the coloring liquid is applied to the zirconia dental ceramics, so it will not cause any effect to the patients. Second, Pre-Sintered Zirconia Coloring Liquid and the predicate device both use inorganic pigments(Ferric chloride and erbium chloride belong to inorganic salts). This does not raise any safety concerns as the product is tested for biocompatibility. The inorganic pigments we use also have long established safety profiles.

Comment 3

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 Pre-Sintered Zirconia Coloring Liquid 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 Pre-Sintered Zirconia Coloring Liquid
1.1	Specification	Specification deviation of	Product technical	Pass

ducted on the subject devic Toblo VII 1: Porformance tocting was co

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		requirements
1.2	Appearance	coloring liquid should be (±2 ml).The coloring liquid should be homogeneous and impurity-free liquid.		Pass
1.3	Post-dyeing comparison requirements	After dyeing, there was no significant difference in color between dental specimens and VITA veneer colorimeter or standard dental specimens.		Pass
1.4	Heavy metal content	Heavy metal content (in Pb) less than 10 mg/L.		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-Subchronic systemic toxicity	Pass
2.5	Subchronic systemic toxicity	ISO 10993-11:2017	Non-Acute systemic toxicity	Pass

VIII Clinical Test Conclusion

No clinical study is included in this submission.

IX Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the Pre-Sintered Zirconia Coloring Liquid is as safe as effective, and performs as well as or better than the legally marketed device.

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.