An addition-cure vinyl polysiloxane dental impression material that is used for all crown and bridge, edentulous, orthodontic and implant impression techniques.

Device Description

The product is a kind of addition-cure silicon rubber impression material composed of vinyl polysiloxane and various fillers with neutral smell and applicable to impression in dentistry. This product is mainly composed of a matrix and a catalyst. The matrix is mainly composed of polydimethylsiloxane, vinyl silicone oil, methyl hydrogen polysiloxane, silica dioxide, ,calcium carbonate, and colorants. The catalyst is mainly composed of polydimethylsiloxane, silica dioxide, calcium carbonate, platinum catalyst, and colorants.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called "Elastic Impression Material." It details the comparison with a predicate device and includes information on testing performed.

Here's an analysis to extract the requested information:

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

The document references ISO 4823:2021 for device effectiveness. Without the full standard or more specific details from the submission, the exact acceptance criteria for each parameter as defined by ISO 4823 cannot be fully detailed here. However, the document states: "The product submitted for inspection adopts Type 0 type product. which is based on the requirements of the ISO4823 standard, which divides this product into 0, 1, 2 and 3 type products, and the difference between these 4 types is mainly in the difference of 'consistency' index, and its chemical properties and biological evaluation requirements are consistent, and the Type 0 silicone rubber with the largest consistency is fully representative."

This implies that the device was evaluated against the requirements for a "Type 0" elastic impression material as per ISO 4823. The performance is reported as meeting these requirements, which leads to the conclusion of substantial equivalence.

For Biocompatibility, the device was tested according to ISO 10993 standards. The acceptance criteria for these would be specific to each test (e.g., absence of irritation, cytotoxicity, sensitization). The reported performance is that the device "has been verified in accordance with the above FDA recognized standards."

Acceptance Criteria	Reported Device Performance
Device Effectiveness (ISO 4823:2021)
Consistency (for Type 0 product)	The device adopts Type 0 product and is fully representative of Type 0 silicone rubber with the largest consistency, implying compliance with ISO 4823:2021 requirements for Type 0.
Other chemical properties (as per ISO 4823)	Consistent with predicate device and standard requirements.
Other physical properties (as per ISO 4823)	Consistent with predicate device and standard requirements.
Biocompatibility (ISO 10993)
Irritation (ISO 10993-23:2021)	Verified in accordance with the standard.
Cytotoxicity (ISO 10993-5:2009)	Verified in accordance with the standard.
Skin Sensitization (ISO 10993-10:2021)	Verified in accordance with the standard.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes used for the non-clinical tests (ISO 4823 or ISO 10993). It only mentions that the device "was tested." The data provenance is not specified beyond the fact that the tests were conducted for Beijing OKVD Biological Technology Ltd. in China. Given these are physical/chemical and biocompatibility tests, they are typically conducted in a laboratory setting, not on patient data. No clinical tests were performed, so concepts like retrospective/prospective clinical data do not apply.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable. The evaluations performed are non-clinical (device effectiveness and biocompatibility) and rely on objective measurements against ISO standards. There is no "ground truth" established by experts in the context of clinical interpretation for this type of device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable as there is no clinical data or expert review process described for the test set.

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

No MRMC comparative effectiveness study was done. This device is an impression material, not an AI software or a device that requires human interpretation of outputs.

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

This question is not applicable. The device is a physical impression material, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For device effectiveness (ISO 4823) and biocompatibility (ISO 10993): The "ground truth" is established by the specified requirements and test methodologies within the internationally recognized ISO standards themselves. These standards prescribe objective measurements and criteria, rather than subjective expert consensus or pathology.

8. The sample size for the training set

This question is not applicable. The device is a physical impression material, not an algorithm that requires a training set.

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

This question is not applicable. The device is a physical impression material, not an algorithm that requires a training set.

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 and 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 27, 2024

Beijing OKVD Biological Technology Ltd. % Helen Nan Manager New Risen Enterprise Management Consulting Co.,Ltd Room302, Building 3, Hanggian Mansion, Hanggian Street Wenzhou, Zhejiang 325000 China

Re: K241924

Trade/Device Name: Elastic Impression Material Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: July 1, 2024 Received: July 1, 2024

Dear Helen Nan:

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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-regulatory

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assistance/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,

Bobak Shirmohammadi -S

For 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

Submission Number (if known)

K241924

Device Name

Elastic Impression Material

Indications for Use (Describe)

An addition-cure vinyl polysiloxane dental impression material that is used for all crown and bridge, edentulous, orthodontic and implant impression techniques.

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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Image /page/4/Picture/0 description: The image shows a logo with the letters "OK" in a stylized font. The "O" is gray, while the "K" is green and appears to be made of a ribbon. To the right of the letters, there is the text "BETTER DENTAL BETTER LIFE" in green, followed by Chinese characters. The logo appears to be for a dental or healthcare-related company.

510(k) Summary - K241924 (As required by 21 CFR 807.92(a))

1.0 Submitter Information

· Company: Beijing OKVD Biological Technology Ltd.
· Address: Room 602, 6th Floor, Building 9, No. 22 Linhe Street, Linhe Economic Development Zone, Shunyi District, Beijing, China 101399
· Phone:
· Email: zhangxianghao@okdental.cn
· Contact: Zhang Xianghao
· Date: June 1st 2024

2.0 Device Information

· Trade Name: OK Dental
· Proprietary Name: Elastic Impression Material;
· Classification: Device Class: 2 Review Panel: Dental Regulation Description: Impression Material. Regulation Number: 21 CFR 872.3660 Product Code: ELW

· Predicate Device:

K133071 submitted by Rizhao Huge Dental Industry Co., Ltd

3.Device Description:

4.Indication for Use:

An addition-cure vinyl polysiloxane dental impression material that is used for all crown and bridge, edentulous, orthodontic and implant impression techniques.

Item	Predicate DeviceK	Subject Device	SignificantDifferences
510k	K133071	K241924
CompanyName	Rizhao Huge Dental IndustryCo.,Ltd	Beijing OKVD BiologicalTechnology Ltd.
ProductName	A Silicone Dentistry-ElasticImpression Material;	Elastic Impression Material;	difference
Indicationfor Use	An addition-cure vinylpolysiloxane dental impressionmaterial that is used for all crownand bridge, edentulous,orthodontic and implant	An addition-cure vinylpolysiloxane dental impressionmaterial that is used for all crownand bridge, edentulous,orthodontic and implant	same
	impression techniques.	impression techniques.
Mode ofUse	1.OK Dental Light body/Regularbody wash:A very hydrophilic impressionmaterial used in heavy/wash orputty/wash impression proceduresand capable of capturingextraordinary sub-gingival details.It is used in crown and bridge andall high precision applications.	1.OK Dental Light body/Regularbody wash:A very hydrophilic impressionmaterial used in heavy/wash orputty/wash impression proceduresand capable of capturingextraordinary sub-gingival details.It is used in crown and bridge andall high precision applications.	same
	2.PEFIT Regular body:A regular impression material withsuperior mechanical strength usedin single step impressionprocedures such mouth guards,night guards, orthodontic, andedentulous applications.	2. OK Dental Regular body:A regular impression material withsuperior mechanical strength usedin single step impressionprocedures such mouth guards,night guards, orthodontic, andedentulous applications.
	3.OK Dental Heavy Body:A heavy body impression materialcombining strength, elasticity anddimensional stability to deliver themost accurate impressions. It isused in two-step heavy-washapplications such as for crown andbridge procedures.	3.OK Dental Heavy Body:A heavy body impression materialcombining strength, elasticity anddimensional stability to deliver themost accurate impressions. It isused in two-step heavy-washapplications such as for crown andbridge procedures.
	PrinciplesofOperation	OK Dental is a dental impressionthat takes imprints of hard (teeth)and/or soft tissues. It captures apart or all of a person's dentitionand surrounding structures of oralcavity. The dental impressionforms an imprint (i.e. a 'negative'mold) of teeth and soft tissues,which can then be used to make acast of the dentition. Animpression is made by placing aviscous, thixotropic impressionmaterial into the mouth via adental impression tray. Thematerial, then sets to become anelastic solid, and, when removedfrom the mouth, provides adetailed and stable negative ofteeth.	OK Dental is a dental impressionthat takes imprints of hard (teeth)and/or soft tissues. It captures apart or all of a person's dentitionand surrounding structures of oralcavity. The dental impressionforms an imprint (i.e. a 'negative'mold) of teeth and soft tissues,which can then be used to make acast of the dentition. Animpression is made by placing aviscous, thixotropic impressionmaterial into the mouth via adental impression tray. Thematerial, then sets to become anelastic solid, and, when removedfrom the mouth, provides adetailed and stable negative ofteeth.
		Shelf-life	3 years
		Safety&Effectiveness	Tested according to FDArecognized standards - ISO10993-3、ISO10993-5、ISO10993-10 and ISO 4823

5.Comparison of Required Technology Characteristics:

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Image /page/5/Picture/0 description: The image shows a logo with the letters "OK" in a stylized font. The "O" is gray, and the "K" is green. To the right of the letters, there is the text "BETTER DENTAL BETTER LIFE" in a smaller font. Below that, there are some Chinese characters.

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Image /page/6/Picture/0 description: The image shows a table with four columns. The first column is labeled "The type in Report", the second column is labeled "TYPE3", the third column is labeled "TYPE 0", and the fourth column is labeled "difference". The table appears to be comparing different types of reports and highlighting the differences between them. The logo of OK is on the top left of the image.

the product submitted for inspection adopts Type 0 type product. which is based on the requirements of the ISO4823 standard, which divides this product into 0, 1, 2 and 3 type products, and the difference between these 4 types is mainly in the difference of "consistency" index, and its chemical properties and biological evaluation requirements are consistent, and the Type 0 silicone rubber with the largest consistency is fully representative.

Brief Summary:

First, the subject device - OK Dental(Elastic Impression Material) incorporates the same intended use with the predicate device. Secondly, the subject device shares almost the same design and fundamental technological characteristics with the predicate device, for example: the same principle of operation and mode of use. Thirdly, both their safety and effectiveness have been verified by appropriated standards, thus being equally safe and effective. Though they are different in shelf-life, such different will not affect the core usage of the device, thus will not influencing the comparison of substantial equivalence between the two devices.

6.Discussion of Tests Performed

· Clinical Tests:

Clinical testing has not been conducted on this product.

· Non-Clinical Tests

The subject device was tested to evaluate its safety and effectiveness according to the following standards:

Biocompatibility Test according to

ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation. ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity.

ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization.

Device Effectiveness according to ISO 4823: 2021

7. Conclusion:

First, the subject device - OK Dental(Elastic Impression Material) enjoys the same intended use and similar technological characteristics with the predicate device. Besides, the performance safety and effectiveness of the subject device has been verified in accordance with the above FDA recognized standards, thus being considered to be as safe and effective as the predicate device.

In a word, it is reasonable for us to conclude that the subject device is substantially equivalent to the predicate device according to the above analysis.

Regulation Number and Section

§ 872.3660 Impression material.

(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).