Elastic Impression Material

K241924 · Beijing Okvd Biological Technology , Ltd. · ELW · Dec 27, 2024 · Dental

Device Facts

• Record ID: K241924
• Device Name: Elastic Impression Material
• Applicant: Beijing Okvd Biological Technology , Ltd.
• Product Code: ELW · Dental
• Decision Date: Dec 27, 2024
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

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

Device Story

Addition-cure vinyl polysiloxane dental impression material; composed of matrix (polydimethylsiloxane, vinyl silicone oil, methyl hydrogen polysiloxane, silica dioxide, calcium carbonate, colorants) and catalyst (polydimethylsiloxane, silica dioxide, calcium carbonate, platinum catalyst, colorants). Used by dental professionals to capture negative imprints of hard (teeth) and soft oral tissues. Material placed in mouth via dental impression tray; sets to elastic solid. Provides detailed, stable negative mold for subsequent cast creation. Used in clinical dental settings for high-precision applications including crown/bridge, edentulous, orthodontic, and implant procedures.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility verified per ISO 10993-23 (irritation), ISO 10993-5 (cytotoxicity), and ISO 10993-10 (sensitization). Effectiveness verified per ISO 4823:2021.

Technological Characteristics

Addition-cure vinyl polysiloxane silicone rubber. Components: polydimethylsiloxane, vinyl silicone oil, methyl hydrogen polysiloxane, silica dioxide, calcium carbonate, platinum catalyst, colorants. Thixotropic. Complies with ISO 4823:2021 (Type 0).

Indications for Use

Indicated for patients requiring dental impressions for crown and bridge, edentulous, orthodontic, and implant procedures.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (Special Controls).

Predicate Devices

• A Silicone Dentistry-Elastic Impression Material (K133071)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: [e-mail]
- · 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:

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.

#### 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 | Significant<br>Differences |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k | K133071 | K241924 | |
| Company<br>Name | Rizhao Huge Dental Industry<br>Co.,Ltd | Beijing OKVD Biological<br>Technology Ltd. | |
| Product<br>Name | A Silicone Dentistry-Elastic<br>Impression Material; | Elastic Impression Material; | difference |
| Indication<br>for Use | An addition-cure vinyl<br>polysiloxane dental impression<br>material that is used for all crown<br>and bridge, edentulous,<br>orthodontic and implant | An addition-cure vinyl<br>polysiloxane dental impression<br>material that is used for all crown<br>and bridge, edentulous,<br>orthodontic and implant | same |
| | impression techniques. | impression techniques. | |
| Mode of<br>Use | 1.OK Dental Light body/Regular<br>body wash:<br>A very hydrophilic impression<br>material used in heavy/wash or<br>putty/wash impression procedures<br>and capable of capturing<br>extraordinary sub-gingival details.<br>It is used in crown and bridge and<br>all high precision applications. | 1.OK Dental Light body/Regular<br>body wash:<br>A very hydrophilic impression<br>material used in heavy/wash or<br>putty/wash impression procedures<br>and capable of capturing<br>extraordinary sub-gingival details.<br>It is used in crown and bridge and<br>all high precision applications. | same |
| | 2.PEFIT Regular body:<br>A regular impression material with<br>superior mechanical strength used<br>in single step impression<br>procedures such mouth guards,<br>night guards, orthodontic, and<br>edentulous applications. | 2. OK Dental Regular body:<br>A regular impression material with<br>superior mechanical strength used<br>in single step impression<br>procedures such mouth guards,<br>night guards, orthodontic, and<br>edentulous applications. | |
| | 3.OK Dental Heavy Body:<br>A heavy body impression material<br>combining strength, elasticity and<br>dimensional stability to deliver the<br>most accurate impressions. It is<br>used in two-step heavy-wash<br>applications such as for crown and<br>bridge procedures. | 3.OK Dental Heavy Body:<br>A heavy body impression material<br>combining strength, elasticity and<br>dimensional stability to deliver the<br>most accurate impressions. It is<br>used in two-step heavy-wash<br>applications such as for crown and<br>bridge procedures. | |
| | Principles<br>of<br>Operation | OK Dental is a dental impression<br>that takes imprints of hard (teeth)<br>and/or soft tissues. It captures a<br>part or all of a person's dentition<br>and surrounding structures of oral<br>cavity. The dental impression<br>forms an imprint (i.e. a 'negative'<br>mold) of teeth and soft tissues,<br>which can then be used to make a<br>cast of the dentition. An<br>impression is made by placing a<br>viscous, thixotropic impression<br>material into the mouth via a<br>dental impression tray. The<br>material, then sets to become an<br>elastic solid, and, when removed<br>from the mouth, provides a<br>detailed and stable negative of<br>teeth. | OK Dental is a dental impression<br>that takes imprints of hard (teeth)<br>and/or soft tissues. It captures a<br>part or all of a person's dentition<br>and surrounding structures of oral<br>cavity. The dental impression<br>forms an imprint (i.e. a 'negative'<br>mold) of teeth and soft tissues,<br>which can then be used to make a<br>cast of the dentition. An<br>impression is made by placing a<br>viscous, thixotropic impression<br>material into the mouth via a<br>dental impression tray. The<br>material, then sets to become an<br>elastic solid, and, when removed<br>from the mouth, provides a<br>detailed and stable negative of<br>teeth. |
| | | Shelf-life | 3 years |
| | | Safety&Eff<br>ectiveness | Tested according to FDA<br>recognized standards - ISO<br>10993-3、ISO10993-5、<br>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.