Vonflex S Putty

K152518 · Vericom Co., Ltd. · ELW · Nov 30, 2015 · Dental

Device Facts

• Record ID: K152518
• Device Name: Vonflex S Putty
• Applicant: Vericom Co., Ltd.
• Product Code: ELW · Dental
• Decision Date: Nov 30, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

It is used for all crown, bridge and orthodontic impression techniques.

Device Story

Vonflex S Putty is an addition-polymerization vinyl polysiloxane dental impression material. It is used by dental professionals in clinical settings to create precise impressions of oral tissues. The material is hand-kneaded and applied to the patient's oral cavity to capture the shape of teeth and surrounding structures. The resulting impression allows the clinician to create accurate dental models for restorative or orthodontic procedures, facilitating clinical decision-making and treatment planning.

Clinical Evidence

Bench testing only. Performance evaluated against ISO 4823 standards, including dimensional accuracy, consistency, reproduction detail, and strain in compression. Biocompatibility testing performed per ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization and irritation), and ISO 10993-3 (Ames test).

Technological Characteristics

Vinyl polysiloxane impression material; ISO 4823 Type 0 classification; hand-kneaded manipulation; 1:1 mixing ratio. Biocompatibility per ISO 10993.

Indications for Use

Indicated for dental patients requiring crown, bridge, or orthodontic impressions.

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

• Delikit Putty, Sherpa Korea (K103346)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 30, 2015

Vericom Co., Ltd. Myung-Hwan Oh R&D Center, Dental 48, Toegyegongdan 1-Gil Chuncheon-si, Gangwon-Do 200-944 REPUBLIC OF KOREA

Re: K152518

Trade/Device Name: Vonflex S Putty Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: July 28, 2015 Received: September 3, 2015

Dear Myung-Hwan Oh:

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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number K _152518

Device Name: Vonflex S™ Putty

Indication for use:

It is used for all crown, bridge and orthodontic impression techniques.

Prescription Use OR (Per 21 CFR Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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## 510(k) Summary

This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: July 28, 2015

- 1. Company making the submission:

| | Submitter |
|----------|------------------------------------------------------------------------------------|
| Name | VERICOM Co., Ltd. |
| Address | 48, Toegyegongdan 1-Gil,<br>Chuncheon-Si, Gangwon-Do,<br>Republic of Korea 200-944 |
| Phone | [phone] |
| Fax | [phone] |
| Contact | Myung-Hwan Oh<br>[e-mail] |
| Internet | www.vericom.co.kr |

## 2. Device:

Proprietary Name - Vonflex STM Putty Common Name - Impression Materials Classification Name - Material, Impression

- 3. Predicate Device:
Delikit Putty, Sherpa Korea, K103346

- 4. Description:
Vonflex STM Putty, as the additional polymerization silicone type, is composed of vinyl polysiloxane impression materials that make oral tissue shape precisely. polychoxane improofien materials that natio of a looks probobility, helps to make precise impression taking.

- 5. Indication for use:
It is used for all crown, bridge and orthodontic impression techniques.

48, Toegyegongdan 1-Gil, Chuncheon-Si, Gangwon-Do 200-944, Korea

Image /page/3/Picture/16 description: The image shows the logo for Vericom Dental Materials. The logo consists of the word "VERICOM" in white letters inside of a red curved shape. Below the curved shape are the words "Dental materials" in a smaller, sans-serif font.

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- 6. Technological Characteristics and Performance Testing:
Vonflex S™ Putty has compared to the predicate device with regard to indications for use, physical properties and etc. The evaluation items are in accordance with the requirements of ISO 4823. According to the test results, Vonflex S™ Putty is substantially equivalent to the predicate device.

Biocompatibility tests have been performed to assure biological safety in consideration of the ISO 10993. Vonflex S™ Putty is tested through the following test: Cytotoxicity (ISO 10993-5), Sensitization and Irritation (ISO 10993-10) and In vitro genotoxicity (Ames test) (ISO 10993-3). The conclusion of the assessments is that Vonflex S™ Putty is biocompatible for its intended use.

Comparison table

| | Subject Device | Predicate Device | Summary |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K)<br>Number | N/A | K103346 | - |
| Proprietary<br>name | Vonflex S™ Putty | Delikit Putty | - |
| Manufacturer | VERICOM CO., LTD. | Sherpa Korea | |
| Indications<br>for use | It is used for all crown,<br>bridge and orthodontic<br>impression techniques. | It is an addition-cure<br>vinyl polysiloxane dental<br>impression material that is<br>used for all crown and<br>bridge, edentulous,<br>orthodontic and implant<br>impression techniques. | The indication for use<br>of the subject and<br>predicate device is to<br>make impression<br>taking, but it is not<br>limited to the<br>applications listed in<br>the indications for<br>use. |
| Standard<br>conformed | ISO4823 | ISO4823 | Claims are the same |
| Physical<br>properties | - Classification according to<br>ISO4823: Type 0<br>- Dimensional accuracy:<br>Max.1.5%<br>- Consistency: Max. 35mm<br>- Compatibility with the die<br>and cast materials:<br>75μm reproduction<br>- Curve of the shrinkage<br>(Strain in compression):<br>Min.0.8 ~ Max.20% | - Classification according<br>to ISO4823: Type 0<br>- Dimensional accuracy:<br>Max. 1.5%<br>- Consistency: Max.35mm<br>- Compatibility with the die<br>and cast materials:<br>75μm reproduction<br>- Curve of the shrinkage<br>(Strain in compression):<br>Min.0.8 ~ Max.20% | The classification of<br>the subject and<br>predicate device is<br>complied with ISO<br>4823 (Type 0).<br>According to the<br>description and<br>bench test result, the<br>physical properties of<br>the subjective<br>devices are similar to<br>these of the<br>predicate device. |
| Raw Material | Vinyl polysiloxane | Vinyl polysiloxane | Claims are the same |
| Mixing Ratio | 1:1 | 1:1 | Claims are the same |
| Method of<br>Manipulation | Hand-kneaded mixes | Hand-kneaded mixes | Claims are the same |

48, Toegyegongdan 1-Gil, Chuncheon-Si, Gangwon-Do 200-944, Korea

Image /page/4/Picture/8 description: The image shows the logo for Vericom Dental Materials. The logo consists of the word "VERICOM" in white letters on a red, curved background. Below the logo, the words "Dental materials" are written in a smaller, black font.

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- 7. Conclusions :
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification, Vericom Co., Ltd. concludes that Vonflex S™ Putty is substantially equivalent to predicate devices as described herein.

- 8. Vericom Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA.
END

Image /page/5/Picture/6 description: The image shows the logo for Vericom Dental Materials. The logo consists of the word "VERICOM" in white letters inside of a red curved shape. Below the red shape, the words "Dental materials" are written in a smaller, black font.