The device is made from PMMA (polymethylmethacrylate) for the fabrication of temporary crowns and bridges and is intended for use in the oral cavity for up to six (6) months while awaiting a permanent restorations are designed and manufactured by a dental Professional (Technician) using CAD technology.

Device Description

The Aidite Pmma is a homogeneous high polymer material made from PMMA (polymethylmethacrylate) added with cross-linking agents to improve the network structure through a unique polymerization molding technology. The device is for the fabrication of temporary crowns and bridges and is intended for use in the oral cavity for up to six months while awaiting a permanent restoration. Restorations are designed and manufactured by a dental professional (such as a dentist) using CAD technology.

The proposed device contains two models with different shape: Cylinder and Cuboid. There are 40 specifications for Cylinder model (variation in different diameters and heights), and 24 specifications for Cuboid model (variation in different lengths, widths, and heights).

There are 17 various shades of the proposed device: 1 is transparent (without color added), the other 16 shades are colored (with different coloring matters added). The 16 shades created based on 16 Vita Shades contain A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, and D4.

The Aidite Pmma would be produced on the 40 specifications of Cylinder model or 24 specifications of Cuboid model, with a shade chosen from the 17 various shades.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Aidite PMMA device, based on the provided FDA 510(k) summary:

The device in question is "Aidite Pmma", a polymethylmethacrylate (PMMA) material for fabricating temporary crowns and bridges, intended for oral use up to six months while awaiting permanent restoration. Restorations are designed and manufactured by a dental professional using CAD technology.

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (K141421), rather than setting explicit new performance acceptance criteria with specific numerical targets outside of established ISO standards. Therefore, the "acceptance criteria" are implied by compliance with ISO and ASTM standards and performance being "substantially equivalent" to the predicate.

Performance Characteristic	Acceptance Criteria (Implied by Standards/Predicate Equivalence)	Reported Device Performance
Material/Composition	PMMA with cross-linking agents	PMMA with cross-linking agents (Same as predicate)
Flexural Strength	≥ 50 MPa (ASTM F1980, ISO 10477)	≥ 50 MPa (Same as predicate)
Shelf Life	2 years (Proven by accelerated aging)	2 years (Predicate has 5 years, but 2 years proven for proposed)
Biocompatibility	Compliant with ISO 10993 and ISO 7405 standards	Tested in accordance with ISO 10993-1, -3, -5, -10, -11 and ISO 7405 standards (Acceptance met based on "adequacy" statement in 510k, though specific results not provided)
Surface Finish	Compliant with ISO 10477	Meets acceptance criteria (Specific value not provided)
Bond Strength	Compliant with ISO 10477	Meets acceptance criteria (Specific value not provided)
Water Sorption	Compliant with ISO 10477	Meets acceptance criteria (Specific value not provided)
Solubility	Compliant with ISO 10477	Meets acceptance criteria (Specific value not provided)
Shade Consistency	Compliant with ISO 10477 and ISO 7491	Evaluated and meets acceptance criteria (Specific details not provided)
Color Stability	Compliant with ISO 10477 and ISO 7491	Evaluated and meets acceptance criteria (Specific details not provided)

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify exact sample sizes for each test mentioned (e.g., biocompatibility sub-tests, mechanical properties). It states that tests were conducted according to specific ISO and ASTM standards. These standards would typically define appropriate sample sizes for each test type.

Data Provenance: The studies were conducted by Aidite (Qinhuangdao) Technology Co., Ltd. in China. The document does not explicitly state "retrospective" or "prospective" but these are non-clinical performance tests and biocompatibility tests typically performed in a laboratory setting for device clearance, implying they are purpose-built tests for this submission (prospective in that sense).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This section is not applicable to this type of 510(k) submission. This device is a dental material, and the "ground truth" is established through adherence to international standards for material properties and biocompatibility. There is no concept of "expert consensus ground truth" or "adjudication" in the context of mechanical, physical, or chemical lab testing of materials.

4. Adjudication Method for the Test Set

Not applicable. See explanation above. Adjudication methods like 2+1 or 3+1 are relevant for interpreting complex medical imaging or clinical outcomes by multiple human readers, not for standardized material property testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. This type of study assesses the interpretive performance of human readers, sometimes with and without AI assistance, typically in diagnostic imaging. It is not relevant for a material science device like Aidite Pmma.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a material, not a software algorithm or AI.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is established by:

International Standards: Adherence to specific parameters and methodologies defined in standards such as ISO 10477 (Dentistry-Polymer-based crown and bridge materials), ISO 7491 (Dental materials-Determination of color stability), ISO 10993 series (Biological evaluation of medical devices), and ASTM F1980 (Standard Guide for Accelerated Aging of Sterile Medical Device Packages).
Predicate Device Equivalence: Demonstrating that its characteristics and performance are "substantially equivalent" to a legally marketed predicate device (K141421), implying that the predicate's established safety and effectiveness serve as a benchmark.

8. The Sample Size for the Training Set

Not applicable. This is a physical dental material, not a machine learning or AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

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

Summary

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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.

December 17, 2020

Aidite (Qinhuangdao) Technology Co., Ltd. % Jessie You Official Correspondent Shenzhen Joyantech Consulting Co., Ltd NO. 55 Shizhou middle road , Nanshan District Shenzhen, GD755 CHINA

Re: K190217

Trade/Device Name: Aidite Pmma Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: Class II Product Code: EBG Dated: November 26, 2020 Received: December 4, 2020

Dear Jessie You:

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.

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

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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, M.ChE. Assistant 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) K190217

Device Name Aidite Pmma

Indications for Use (Describe)

The device is made from PMMA (polymethylmethacrylate) for the fabrication of temporary crowns and is intended for use in the oral cavity for up to six (6) months while awaiting a permanent restorations are designed and manufactured by a dental Professional (Technician) using CAD technology.

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)

imption 500 (Part 21 CFR 1301, Subpart B)

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

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510(k) Summary

1. Submission Sponsor

Applicant Name	Aidite (Qinhuangdao) Technology Co., Ltd.
Address	No.9 Dushan Road, Economic and Technological
	Development Zone, Qinhuangdao, Hebei, China.
Post Code	066000
Phone No.	+86 335 8587898
Fax No.	+86 335 8587198
Contact Person	Ms. Zhang Wei
E-mail	zhangwei@aidite.com
Date Prepared	2020-12-10

2. Submission correspondent

Name	Shenzhen Joyantech Consulting Co., Ltd
Address	Room 1122, No.55 Shizhou Middle Road, NanshanDistrict,Shenzhen,Guangdong,P.R.China
Image: Company Logo
Post Code	518000
Phone No.	86-755-86069197
Contact Person	Mr. Field Fu; Ms. Jessie You; Ms. Elly Xu
Email	Jessie@cefda.com; Elly@cefda.com

3. Devices Identification

Trade name	Aidite Pmma
Models	Cylinder and Cuboid
Device class	II
Classification name	Crown and Bridge, Temporary, Resin
Product code	EBG
Regulation number	21 CFR 872.3770
Regulation description	Temporary crown and bridge resin
Regulation medical specialty	Dental

4. Legally Marketed Predicate Devices

Trade name	PMMA Block
510(K) Number	K141421
Manufacturer	Rizhao Huge Dental Industry Co., Ltd
Device class	II

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Classification name	Crown and Bridge, Temporary, Resin
Product code	EBG
Regulation number	21 CFR 872.3770
Regulation description	Temporary crown and bridge resin
Regulation medical specialty	Dental

5. Device Description

The Aidite Pmma would be produced on the 40 specifications of Cylinder model or 24 specifications of Cuboid model, with a shade chosen from the 17 various shades.

6. Indications for Use Statement

7. Substantial Equivalence Discussion

Table 1: Substantial equivalence comparison
---------------------------------------------	--	--

Items	Proposed device	Predicate device	Comments
Trade name	Aidite Pmma	PMMA Block	/
510(K)submitter	Aidite (Qinhuangdao)Technology Co., Ltd.	Rizhao Huge DentalIndustry Co., Ltd	/
510(K) number	K190217	K141421	/
Classification	21 CFR 872.3770	21 CFR 872.3770	Same

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regulation	Temporary crown andbridge resin	Temporary crown andbridge resin	Temporary crown andbridge resin
Classificationand productcode	IIEBG	IIEBG	Same
Indication foruse	The device is made fromPMMA(polymethylmethacrylate) for the fabrication oftemporary crowns andbridges and is intendedfor use in the oral cavityfor up to six (6) monthswhile awaiting apermanent restoration.Restorations aredesigned andmanufactured by adental Professional(Technician) using CADtechnology.	A device made fromPMMA(polymethylmethacrylate) for the fabrication oftemporary crowns andbridges and is intendedfor use in the oral cavityfor up to six (6) monthswhile awaiting apermanent restoration.Restorations aredesigned andmanufactured by adental Professional(Technician) using CADtechnology.	Same
Material ofconstruction	PMMA	PMMA	Same
Shades	17 Shades(Transparent, 16 VitaShades)	20 Vita Shades	DifferentIssue 1
Processingmethod	Variable ThicknessMilling Blank andmachined using anymilling system	Variable ThicknessMilling Blank andmachined using anymilling system	Same
Flexuralstrength	≥50 MPa	≥50 MPa	Same
Shelf life	2 years	5 years	DifferentIssue 2
Performanceeffectiveness	Tested according to ISO10477	Tested according to ISO10477	Same
Performancesafety	Tested according to ISO10993 standards	Tested according to ISO10993 standards	Same

lssue 1: The transparent shade is made from PMMA without color added. The 16 Vita shades are designed in accordance with VITA classical A1-D4. The shade consistency, color stability and the biocompatibility of Aidite Pmma has been evaluated by conducting tests.

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Issue 2: The 2-year shelf life of the proposed device has been proved by conducting accelerated aging test.

8. Non-Clinical Performance Data

1) Biocompatibility test

The Aidite Pmma is classified as surface-contacting device. For duration of contact, the Aidite Pmma is considered as permanent contact devices. In accordance with ISO 10993-1 and ISO 7405, the biocompatibility tests contain: ISO 7405: 2008 & ISO 10993-5: 2009 Agar diffusion test ISO 7405: 2008 & ISO 10993-5: 2009 Filter diffusion test ISO 10993-5: 2009 In Vitro cytotoxicity test ISO 10993-10: 2010 Skin sensitization test ISO 10993-10: 2010 Oral mucosa irritation test ISO 10993-11: 2017 Subchronic systemic toxicity ISO 10993-3: 2014 Genotoxicity

2) Shelf life validation test

The shelf life validation test of the proposed devices was conducted after accelerated aging for 2 years (ASTM F 1980):

Performance test-bench 3)

The performance of Aidite Pmma contains surface finish, flexural strength, bond strength, water sorption and solubility, shade consistency and color stability. All the results meet the acceptance criteria, they also demonstrate that the Aidite Pmma meet the performance characteristics and are substantially equivalent to the legally marketed predicate devices. The performance tests were conducted in accordance with the following standards:

ISO 10477: 2018 Dentistry-Polymer-based crown and bridge materials; ISO 7491: 2000 Dental materials-Determination of color stability.

9. Statement of Substantial Equivalence

The Indications for Use and technological characteristics for Aidite Pmma are same to the referenced predicate devices (K141421). The non-clinical performance testing demonstrates that the proposed device is substantially equivalent to the predicate devices. Therefore, the results show that it is Substantially Equivalent (SE) between the proposed device and the predicate device.

Regulation Number and Section

§ 872.3770 Temporary crown and bridge resin.

(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.