Dental Ceramic divided into two categories: Metal Ceramic; Zirconia Ceramic. They are used to be made for simulation tooth of human whose ages above 18. After fired, form the whole or part of a dental restoration or prosthesis. It is made by Aluminium oxide(Al2O3), Silicon dioxide (SiO2), Potassium carbonate (K2CO3), Sodium carbonate (Na2CO3), Calcium oxide (CaO), Zirconium dioxide (ZrO2).

Metal Ceramic: a complete metallic substructure of Dental Ceramic are Glaze separated two parts-metal and ceramic, which is made of metal alloys and whose inner is a framework. The materials within the metallic is broadly divided into three categories: precious metal, semiprecious metal alloys and non-precious metal alloys, being usually called inner alloy crown.

Zirconia Ceramic: A complete Zirconia Ceramics are separated two parts-Zirconia coping and porcelain layer (Dentin layer and Enamel layer), as shown in the figure, the innermost layer of dental ceramic is Zirconia coping which is a framework. It has a positive impact on bearing and combining closely with the dentin layer.

AI/ML Overview

The provided text describes a 510(k) summary for a dental ceramic device, which does not contain information about an AI/ML powered device. Therefore, a description of acceptance criteria and studies related to AI/ML performance is not applicable. The document focuses on demonstrating substantial equivalence to a predicate device through material composition, mechanical properties (flexural strength, solubility, glass transition temperature), and biocompatibility testing.

Here's the information extracted from the provided text, structured to align with the prompt's request where applicable for non-AI devices:

1. Table of Acceptance Criteria and Reported Device Performance

Feature	Acceptance Criteria (from ISO 6872)	Reported Device Performance
Metal Ceramic
Opaque Flexural Strength	Met ISO 6872 requirements	98.63 MPa
Dentine Flexural Strength	Met ISO 6872 requirements	98.07 MPa
Enamel Flexural Strength	Met ISO 6872 requirements	102.48 MPa
Opaque Solubility	Met ISO 6872 requirements	15.88 µg.cm-2
Dentine Solubility	Met ISO 6872 requirements	36.77 µg.cm-2
Enamel Solubility	Met ISO 6872 requirements	18.40 µg.cm-2
Opaque Glass Transition Temp.	Met ISO 6872 requirements	575°C
Dentine Glass Transition Temp.	Met ISO 6872 requirements	575°C
Enamel Glass Transition Temp.	Met ISO 6872 requirements	575°C
Zirconia Ceramic
Dentine Flexural Strength	Met ISO 6872 requirements	92.56 MPa
Enamel Flexural Strength	Met ISO 6872 requirements	98.87 MPa
Dentine Solubility	Met ISO 6872 requirements	18.17 µg.cm-2
Enamel Solubility	Met ISO 6872 requirements	28.60 µg.cm-2
Dentine Glass Transition Temp.	Met ISO 6872 requirements	590°C
Enamel Glass Transition Temp.	Met ISO 6872 requirements	590°C
Biocompatibility	Met ISO 10993-1, -3, -5, -10, -11, USP40<151> requirements	Met the requirements of ISO 10993-1, -3, -5, -10, -11, USP40<151>

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

Test set sample size: Not explicitly stated for performance testing (mechanical properties) or biocompatibility. The results are presented as single values for each material property type (e.g., flexural strength).
Data provenance: Not explicitly stated (e.g., country of origin). The studies appear to be laboratory-based material characterization studies conducted by the manufacturer or a contracted lab.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is not an AI/ML product where expert consensus for ground truth is typically required. The ground truth for material properties is established by recognized international standards (ISO 6872 and ISO 10993).

4. Adjudication method for the test set: Not applicable. This device does not involve subjective assessment requiring 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 dental ceramic material, not an AI/ML diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used:

Mechanical Performance: Ground truth is established by the requirements and methodologies defined in ISO 6872:2008 (and comparison to ISO 6872:2015) for Dentistry - Ceramic materials.
Biocompatibility: Ground truth is established by the requirements and methodologies defined in ISO 10993 series and USP40<151> for biological evaluation of medical devices.

8. The sample size for the training set: Not applicable. This device is a material, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

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.

May 22, 2019

Baot Biological Technology Co., LTD Ligun Zhu Quality Manager Unit 1, Second Floor, No 12 Building, Yujing Industry Zone, 106 Qihao Road, Torch Development District Zhongshan, 528437 CHINA

Re: K182350

Trade/Device Name: Dental Ceramic Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: Class II Product Code: EIH Dated: February 21, 2019 Received: February 21, 2019

Dear Liqun Zhu:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Malvina Eydelman, M.D. Director 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) K182350

Device Name

Dental Ceramic (Model: Metal Ceramic; Zirconia Ceramic)

Indications for Use (Describe)

Dental Ceramic is indicated for use for metal-ceramic full veneers and for zirconia full veneers and partial veneers.

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

K182350

1. Submitter's Information

The submitter of this pre-market notification is:

Name:	BAOT BIOLOGICAL TECHNOLOGY CO.,LTD
Address:	Unit 1, Second Floor, No 12 Building, Yujing IndustryZone, 106 Qihao Road, Torch Development District,Zhongshan City, Guangdong, P.R. China
	Zip Code: 528437
Company Phone No:	+86 760 87893826
Company Fax No:	+86 760 87893827
Contact Person:	Liqun Zhu
E-mail:	baotw@baot.biz
Date summary prepared:	August 10, 2018

2. Device Identification

Device Trade Name:	Dental Ceramic (Model: Metal Ceramic; ZirconiaCeramic)
Classification Name	powder, porcelain
Regulation Number:	21 CFR 872.6660
Regulation Name:	Porcelain Powder For Clinical Use
Regulation Class:	II
Product Code:	FIH

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004 510(k) summary

3. Predicate Devices

Device Trade Name:	Luminesse Porcelain System
510(k) Number;	K140848
Regulation Name:	Porcelain Powder For Clinical Use
Class:	II
Classification Panel:	Dental
Product Code:	EIH
Regulation Number:	21 CFR 872.6660

4. Device Description

Dental Ceramic divided into two categories: Metal Ceramic; Zirconia Ceramic.

They are used to be made for simulation tooth of human whose ages above 18. After fired, form the whole or part of a dental restoration or prosthesis. It is made by Aluminium oxide(Al2O3), Silicon dioxide (SiO2), Potassium carbonate (K2CO3), Sodium carbonate (Na2CO3), Calcium oxide (CaO), Zirconium dioxide (ZrO2),

Metal Ceramic :a complete metallic substructure of Dental Ceramic are Glaze separated two parts-metal and ceramic, which is made of metal alloys and whose inner is a framework. The materials within the metallic is broadly divided into three categories: precious metal, semiprecious metal alloys and non-precious metal alloys, being usually called inner alloy crown.

Zirconia Ceramic : A complete Zirconia Ceramics are separated two parts-Zirconia coping and porcelain layer (Dentin layer and Enamel layer), as shown in the figure, the innermost layer of dental ceramic is Zirconia coping which is a framework. It has a positive impact on bearing and combining closely with the dentin layer.

5. Intended Use / Indications for Use

Dental Ceramic is indicated for use for metal-ceramic full veneers and partial veneers and for zirconia full veneers and partial veneers.

6. Substantial Equivalence

A comparison of the relevant technological characteristics between the subject and primary predicate devices is provided in the table that follows.

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004_510(k) summary

Feature	Our device	Luminesse Porcelain (K140848)	Comments
Indications ForUse:	Dental Ceramic isindicated for use formetal-ceramic full veneersand partial veneers andfor zirconia full veneersand partial veneers.	The Luminesse Porcelain Systemis dental porcelain material to beused in conjunction with metal,zirconia, or pressable ceramicframework in the construction ofcrowns and/or bridgework andveneers.	DifferentThe description of theintended use isdifferent, but it is thesame as productform, the actual useand methods, and thechange of descrptionfor IFU does notcause unknownsafety problems.
Chemicalcomposition	Aluminium oxide(Al2O3),Silicon dioxide (SiO2),Potassium carbonate(K2CO3), Sodiumcarbonate (Na2CO3),Calcium oxide (CaO),Zirconium dioxide (ZrO2)	Equivalent devices are comparedwith predicate products(K981490), the comments showsthat Most all oxides are present inboth Luminesse High-Fusing andWilli Geller Creation CC porcelain,it included varying proportions ofsilicon dioxide, aluminum dioxide,sodium oxide, potassium oxide,tin oxide, barium oxide and ironoxide. Chemically stable mixedmetal oxides, including spinel,baddeleyit, zircon, and periclasephases of zirconium, iron, cobalt,chromium, yttrium, cerium, nickeland zinc oxides, are used in traceamounts for pigmentation. Thepaste opaques are comprised ofceramic powder fitting thisdescription suspended in glycerol,zinc chloride, sodium acetate,propandiol, and aerosol. Thestains are composed of silicondioxide, aluminum oxide, potassiumoxide, tin oxide, barium oxide,	DifferentThe predicate devicestate that it includedvarying proportions ofsilicon dioxide,aluminum dioxide,sodium oxide,potassium oxide, tinoxide, barium oxideand iron oxide.We performedBiocompatibility testand ISO 6872 test,the test result showsthat Components ofour product metrequirements ofbiocompatibility andperformance. Thedifference does notcause unknownsafety problems.
		iron oxide, and calcium oxide, andchemically stable mixed metaloxides for pigmentation.
ClassificationCode	21 CFR 872.6660Product Code: EIH	21 CFR 872.6660Product Code: EIH	Same
Flexuralstrength	METAL CERAMICOPAQUE :98.63MPaDENTINE :98.07MpaENAMEL :102.48MpaZIRCONIA CERAMICDENTINE :92.56MPaENAMEL :98.87MPa	Met the requirements of ISO 6872	The predicatedevice(K140848) donot list the maintechnologicalcharacteristic in the510(k) summary, itjust state that Benchtesting to determineflexural strength,solubility, and glass
Solubility	METAL CERAMICOPAQUE :15.88µg.cm-2DENTINE :36.77µg.cm-2ENAMEL :18.40µg.cm-2ZIRCONIA CERAMICDENTINE :18.17µg.cm-2ENAMEL :28.60µg.cm-2	Met the requirements of ISO 6872	transition temperaturewas conducted inaccordance with ISO6872.We also performedthe bench test inaccordance with ISO6872. The test resultscan prove our productmet the requirements
Glass transitiontemperature	METAL CERAMICOPAQUE :575°CDENTINE : 575°CENAMEL : 575°CZIRCONIA CERAMICDENTINE : 590°CENAMEL : 590°C	Met the requirements of ISO 6872	of ISO 6872, we thinkthe lack ofperformance data ofpredicate device donot does not causeunknown safetyproblems.
Biocompatibility	Met the requirements ofISO 10993-1,-3,-5,-10,-11,USP40<151>	Components of this product havenot changed in any way from thepredicate that would adverselyaffect biocompatibility; therefore,	DifferentWe performed ISO10993 test to prove
	it is determined that nobiocompatibility testing isnecessary for this product.	our product'sbiocompatibility.

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004_510(k) summary

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7. Biocompatibility Testing

Our product belong to external communicating device which contact dentin more than 30 days, we have conducted biological evaluations based on the requirements of ISO 10993-1 and other similar dental materials, as below :

Ames Test ISO 10993-3 Biological evaluation of medical devices Part 3: Tests for i genotoxicity, carcinogenicity and reproductive toxicity.
-In Vitro Cytotoxicity Test - ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
-Oral MucOsa Irritation - ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
-Skin sensitization - ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
Pyrogen Test ISO 10993-11 and USP40<151>Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
-Acute systemic Toxicity Test - ISO 10993-11 Biological evaluation of medical devices -Part 11: Tests for systemic toxicity
Subchronic systemic Toxicity Test ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

8. Performance testing :

Performance testing was conducted in accordance with ISO 6872:2008 Dentistry - Ceramic materials. The Dental Ceramic is classified as a Type I, Class 1 device and met the standard requirements per ISO 6872:2015. We also provided a comparison between ISO 6872:2008 and ISO 6872:2015, effects of changes to materials properties.

9. Conclusions:

It has the same technological characteristics, manufacturing process, and similar intended use, chemical composition, as the predicate devices. Our products are substantially equivalent as its predicate 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.