Vonflex S

K152615 · Vericom Co., Ltd. · ELW · Nov 3, 2016 · Dental

Device Facts

• Record ID: K152615
• Device Name: Vonflex S
• Applicant: Vericom Co., Ltd.
• Product Code: ELW · Dental
• Decision Date: Nov 3, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

Impression material in a dual phase impression technique Precise duplication of models Capturing multiple unit impressions Impression of inlay, crown, bridge and partial denture etc.

Device Story

Vonflex S is a hydrophilic vinyl polysiloxane (VPS) impression material used in dental clinics by practitioners. It consists of two components (base and catalyst) mixed in a 1:1 ratio, available in light, medium, and heavy-bodied consistencies. The material is supplied in cartridges or tubes and features both normal and fast-setting options. The clinician applies the material to the patient's oral cavity to capture precise anatomical impressions of teeth and surrounding tissues. The contrasting colors of the base and catalyst allow the operator to verify proper mixing. The resulting impression is used to create accurate dental models for the fabrication of restorations such as crowns, bridges, and dentures. The material's hydrophilic properties and dimensional accuracy facilitate high-fidelity reproduction of oral structures, aiding in the clinical fit and success of dental prosthetics.

Clinical Evidence

Bench testing only. Performance evaluated against ISO 4823 standards, including flow properties, wettability, working/setting times, tear strength, dimensional accuracy, consistency, and compatibility with die/cast materials. Biocompatibility testing conducted per ISO 10993-1, including cytotoxicity (ISO 10993-5), genotoxicity (ISO 10993-3), and oral mucous irritation/sensitization (ISO 10993-10). Results demonstrated no cytotoxicity, genotoxicity, irritation, or sensitization.

Technological Characteristics

Hydrophilic vinyl polysiloxane (VPS) impression material. Composition: vinyl siloxanes, silica/fumed silica filler, hydrogen polysiloxane cross-linker, organo-platinum complex catalyst, pigments, and surfactant. Conforms to ISO 4823. Delivery via cartridges or tubes. Biocompatible per ISO 10993.

Indications for Use

Indicated for dental impression procedures including dual phase techniques, model duplication, multiple unit impressions, and impressions for inlays, crowns, bridges, and partial dentures.

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

• Aquasil Ultra Smart Wetting Impression Material (K113406)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, stacked on top of each other.

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

November 3, 2016

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

Re: K152615

Trade/Device Name: Vonflex S Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: August 10, 2015 Received: September 14, 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.

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

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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

Susan Runno DDS, MA

Tina Kiang, Ph.D. Acting 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

Device Name: Vonflex S™

Indication for use:

- Impression material in a dual phase impression technique
- Precise duplication of models
- Capturing multiple unit impressions
- Impression of inlay, crown, bridge and partial denture etc.

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: August 10, 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 S™ Common Name - Impression Materials Classification Name - Material, Impression Class of device - Class II CFR Number - 872.3660 Product Code - ELW

- 3. Predicate Device:
Aquasil Ultra Smart Wetting Impression Material, DENTSPLY International, K113406

- 4. Description:
Vonflex S™, as the additional polymerization silicone type, is composed of a two component (base and catalyst, mixing ratio 1:1) hydrophilic vinyl polysiloxane impression material for all dental impression techniques. Vonflex S™ consists of light-bodied, medium-bodied or heavy-bodied consistencies in delivery systems of cartridges and/or tubes. It has normal set and fast set that would be desired by the operator.

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

Image /page/3/Picture/14 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 word "VERICOM" are the words "Dental materials" in a smaller, black font.

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- 5. Indication for use:
- Impression material in dual phase impression technique
- Precise duplication of models
- Capturing multiple unit impressions
- Impression of inlay, crown, bridge and partial denture etc.
- 6. Technological Characteristics and Performance Testing:

Vonflex S™ has compared to the predicate device with regard to indications for use, physical and mechanical properties, and chemical composition. Below evaluation items are in accordance with the requirements of FDA guideline & ISO4823.

- Flow properties
- Wettability
- Working time
- Setting reaction time
- Tear strength
- Dimensional accuracy
- Consistency
- Compatibility with the die and cast materials
- Curve of the shrinkage
- Viscosity

According to the test results, the comparison for indications for use, performance data, and chemistry shows that Vonflex S™ is substantially equivalent to the predicate device.

Image /page/4/Picture/20 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 word "VERICOM" are the words "Dental materials" in black font.

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| | Name | | | Vonflex STM Heavy<br>- Normal setting | Vonflex STM Heavy<br>- Fast setting | Aquasil Ultra Rigid Smart<br>Wetting Impression Material | |
|------------|--------------------------------------------------|-----------------------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|----------------------------------------------------------|-------------------------|
| | 510(k) Submitter<br>Number | | | VERICOM CO., LTD.<br>New device | | DENTSPLY International<br>K113406 | |
| | Indications for use | | | - Impression material in dual phase<br>impression technique<br>- Precise duplication of models<br>- Capturing multiple unit<br>impressions<br>- Impression of inlay, crown, bridge<br>and partial denture etc. | | It is indicated for all dental<br>impression techniques. | |
| Similarity | Physical<br>properties | Flow properties | | 3.57 mm | 2.42 mm | 1.82 mm | |
| | | Wettability | | 62.06° | 65.67° | 65.70° | |
| | | Working time | | 2'15" | 1'30" | 2'15"-2'45" | |
| | | Setting reaction time | | 4'00" | 2'30"" | 5'00" | |
| | Tear strength | | | 10.74 N/mm | 8.73 N/mm | 8.51 N/mm | |
| | Dimensional accuracy | | | 0.11% | 0.07% | 0.12% | |
| | Consistency | | | 34.76 mm | 34.78 mm | 34.78 mm | |
| | Compatibility with the<br>die and cast materials | | | Reproduced<br>for 0.05 mm | Reproduced<br>for 0.05 mm | Reproduced for 0.05 mm | |
| | Curve of the shrinkage | | | 2.56% | 2.38% | 1.84% | |
| | Viscosity | Base | | 123,000mPas | 131,000mPas | 136,00mPas | |
| | | Catalyst | | 113,000mPas | 108,000mPas | 101,000mPas | |
| | Vinyl terminated group | | | Vinyl siloxanes | | Polydimethylsiloxane polymer | |
| | Chemical<br>composition | Filler | | Silica, Fumed silica | | Silicon Dioxide,<br>Sodium Aluminosilicate | |
| | | Cross linker | | Hydrogen polysiloxane | | Polymethyl hydrogen siloxane | |
| | Catalyst | | | Organo platinum complex | | Organic platinum complex | |
| | Colorant | | | Pigments | | Pigments | |
| | Surfactant | | | Surfactant | | Surfactant | |
| | Standard Conformed | | | | ISO4823 | | ISO4823 |
| | Biocompatibility | | | | Yes | | Yes |
| | Use | | | | Prescription / Hospital | | Prescription / Hospital |
| Difference | Physical<br>properties | Color | | - Light orange(Light orange/White)<br>- Blue (Blue/White)<br>- Dark green (Dark green/White)<br>- Dark purple (Dark purple/White)<br>- Yellow (Yellow/White) | | - Green<br>(Green/White) | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |

## table - Vonflex STM Heavy

Vonflex S™ Heavy is composed to Vinyl terminated group, Filler, Cross linker, Catalyst, Colorant and Surfactant as the predicate device. Many kinds of filler is used as a thickening agent in the impression materials. In general, Silica is synonym for silicon dioxide. So, The chemical composition of Vonflex S™ Heavy is equivalent to the predicate device, Aquasil Ultra Rigid Smart Wetting impression Material. Indication for use of Vonflex S™ Heavy provide more detailed information than the predicate device for the user to have a better understanding of what Vonflex S™ Heavy is indicated for. Through above table, most physical properties, Indications for use and chemical composition of Vonflex S™ Heavy is similar to these of the predicate device.

The difference between Vonflex S™ Heavy and predicate device is the color. But it doesn't affect to safety and effectiveness of product considerably. The two components of impression materials are requested contrasting colors to check the mixing condition, and the mixture should be distinguished from the oral tissue and blood. In this connection, the colors of Vonflex S™ Heavy and predicate devices are satisfied these conditions.

Image /page/5/Picture/7 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 word "VERICOM" are the words "Dental materials" in black letters.

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| Comparison table - Vonflex ST™ Medium | | | | | |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|--------------------------------------------|
| Name | Vonflex ST™ Medium<br>- Normal setting | Vonflex ST™ Medium<br>- Fast setting | Aquasil Ultra Monophase<br>Smart Wetting Impression<br>Material | | |
| 510(k) Submitter<br>Number | VERICOM CO., LTD.<br>New device | | DENTSPLY International<br>K113406 | | |
| Indications for use | - Impression material in dual phase<br>impression technique<br>- Precise duplication of models<br>- Capturing multiple unit<br>impressions<br>- Impression of inlay, crown, bridge<br>and partial denture etc. | | It is indicated for all dental<br>impression techniques. | | |
| Similarity | Physical<br>properties | Flow properties | 7.04 mm | 6.99 mm | 8.35 mm |
| | | Wettability | 66.19° | 66.63° | 65.98° |
| | | Working time | 2'15" | 1'30" | 2'15"-2'45" |
| | | Setting reaction time | 4'00" | 2'30"" | 5'00" |
| | | Tear strength | 10.43 N/mm | 9.16 N/mm | 15.85 N/mm |
| | | Dimensional accuracy | 0.17% | 0.13% | 0.17% |
| | | Consistency | 40.25 mm | 39.44 mm | 38.78 mm |
| | Chemical<br>composition | Compatibility with the<br>die and cast materials | Reproduced for<br>0.05 mm | Reproduced<br>for 0.05 mm | Reproduced for 0.05 mm |
| | | Curve of the shrinkage | 4.95% | 3.79% | 5.90% |
| | | Viscosity | Base | 85,000mPas | 83,000mPas |
| | | | Catalyst | 107,000mPas | 101,000mPas |
| | | Vinyl terminated group | Vinyl siloxanes | | Polydimethylsiloxane polymer |
| | | Filler | Silica, Fumed silica | | Silicon Dioxide,<br>Sodium Aluminosilicate |
| | | Cross linker | Hydrogen polysiloxane | | Polymethyl hydrogen siloxane |
| | | Catalyst | Organo platinum complex | | Organic platinum complex |
| | | Colorant | Pigments | | Pigments |
| | Surfactant | Surfactant | | Surfactant | |
| | Standard Conformed | | ISO4823 | | ISO4823 |
| | Biocompatibility | | Yes | | Yes |
| | Use | | Prescription / Hospital | | Prescription / Hospital |
| Difference | Physical<br>properties | Color | - Light green(Light green/White)<br>- Green(Green/White)<br>- Yellow(Yellow/White)<br>- Dark purple(Dark purple/White)<br>- Blue(Blue/White) | | - Purple<br>(Purple/White) |

## Vonflav STM Modium

Vonflex S™ Medium is composed to Vinyl terminated group, Filler, Cross linker, Catalyst, Colorant and Surfactant as the predicate device. Many kinds of filler is used as a thickening agent in the impression materials. In general, Silica is synonym for silicon dioxide. So, The chemical composition of Vonflex S™ Medium is equivalent to the predicate device, Aquasil Ultra Monophase Smart Wetting impression Material. Indication for use of Vonflex S™ Medium provide more detailed information than the predicate device for the user to have a better understanding of what Vonflex S™ Medium is indicated for. Through above table, most physical properties, Indications for use and chemical composition of Vonflex S™ Medium is similar to these of the predicate device.

The difference between Vonflex S™ Medium and predicate device is the color. But it doesn't affect to safety and effectiveness of product considerably. The two components of impression materials are requested contrasting colors to check the mixing condition, and the mixture should be distinguished from the oral tissue and blood. In this connection, the colors of Vonflex S™ Medium and predicate devices are satisfied these conditions.

Image /page/6/Picture/7 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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| Comparison table - Vonflex S TM Light | | | | | |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------|--------------------------------------------|
| Name | Vonflex™ S Light<br>- Normal setting | Vonflex™ S Light<br>- Fast setting | Aquasil Ultra LV Smart<br>Wetting Impression Material | | |
| 510(k) Submitter<br>Number | VERICOM CO., LTD.<br>New device | | DENTSPLY International<br>K113406 | | |
| Indications for use | - Impression material in dual phase<br>impression technique<br>- Precise duplication of models<br>- Capturing multiple unit<br>impressions<br>- Impression of inlay, crown, bridge<br>and partial denture etc. | | It is indicated for all dental<br>impression techniques. | | |
| Similarity | Physical<br>properties | | | | |
| | Flow properties | 9.18 mm | 8.60 mm | 8.94 mm | |
| | Wettability | 60.65° | 61.05° | 61.07° | |
| | Working time | 2'30" | 1'30" | 2'15"-2'45" | |
| | Setting reaction time | 4'00" | 2'30"" | 5'00" | |
| | Tear strength | 10.22 N/mm | 10.02 N/mm | 9.97 N/mm | |
| | Dimensional accuracy | 0.08% | 0.09% | 0.15% | |
| | Consistency | 43.43 mm | 42.02 mm | 39.23 mm | |
| | Compatibility with the<br>die and cast materials | Reproduced for<br>0.05 mm | Reproduced for<br>0.05 mm | Reproduced for 0.05 mm | |
| | Curve of the shrinkage | 7.71% | 5.24% | 3.68% | |
| | Viscosity | Base | 51,500mPas | 61,500mPas | 67,500mPas |
| | | Catalyst | 71,000mPas | 83,000mPas | 54,667mPas |
| | Vinyl terminated group | Vinyl siloxanes | | Polydimethylsiloxane polymer | |
| | Chemical<br>composition | Filler | Silica, Fumed silica | | Silicon Dioxide,<br>Sodium Aluminosilicate |
| | | Cross linker | Hydrogen polysiloxane | | Polymethyl hydrogen siloxane |
| Catalyst | | Organo platinum complex | | Organic platinum complex | |
| Colorant | | Pigments | | Pigments | |
| | Surfactant | Surfactant | | Surfactant | |
| | Standard Conformed | ISO4823 | | ISO4823 | |
| | Biocompatibility | Yes | | Yes | |
| | Use | Prescription / Hospital | | Prescription / Hospital | |
| Difference | Physical<br>properties | Color | - Light red(Light red/White)<br>- Red(Red/White)<br>- Blue(Blue/White)<br>- Yellow(Yellow/White)<br>- Dark green(Dark green) | | - Bluish green<br>(Bluish green<br>/White) |

table - Vonflex STM I ight

Vonflex S™ Light is composed to Vinyl terminated group, Filler, Cross linker, Catalyst, Colorant and Surfactant as the predicate device. Many kinds of filler is used as a thickening agent in the impression materials. In general, Silica is synonym for silicon dioxide. So, The chemical composition of Vonflex S™ Light is equivalent to the predicate device, Aquasil Ultra LV Smart Wetting impression Material. Indication for use of Vonflex S™ Light provide more detailed information than the predicate device for the user to have a better understanding of what Vonflex S™ Light is indicated for. Through above table, most physical properties. Indications for use and chemical composition of Vonflex S™ Light is similar to these of the predicate device.

The difference between Vonflex S™ Light and predicate device is the color. But it doesn't affect to safety and effectiveness of product considerably. The two components of impression materials are requested contrasting colors to check the mixing condition, and the mixture should be distinguished from the oral tissue and blood. In this connection, the colors of Vonflex S™ Light and predicate devices are satisfied these conditions.

Image /page/7/Picture/7 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 word "VERICOM" are the words "Dental materials" in a smaller, black font. The logo is simple and professional, and it clearly identifies the company and its products.

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| | Name | | | Vonflex STM<br>Light XLV<br>-Normal setting | Vonflex STM<br>Light XLV<br>-Fast setting | Aquasil Ultra XLV Smart<br>Wetting Impression Material |
|------------|----------------------------|--------------------------------------------------|----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|----------------------------------------------------------|
| | 510(k) Submitter<br>Number | | | VERICOM CO., LTD.<br>New device | | DENTSPLY International<br>K113406 |
| | Indications for use | | | - Impression material in dual phase<br>impression technique<br>- Precise duplication of models<br>- Capturing multiple unit impressions<br>- Impression of inlay, crown, bridge<br>and partial denture etc. | | It is indicated for all dental<br>impression techniques. |
| Similarity | Physical<br>properties | Flow properties | | 23.25 mm | 17.49 mm | 23.26 mm |
| | | Wettability | | 56.98° | 57.40° | 54.96° |
| | | Working time | | 2'30" | 1'30" | 2'15"-2'45" |
| | | Setting reaction time | | 4'00" | 2'30"" | 5'00" |
| | | Tear strength | | 15.98 N/mm | 16.72 N/mm | 15.32 N/mm |
| | | Dimensional accuracy | | 0.08% | 0.11% | 0.17% |
| | | Consistency | | 45.73 mm | 45.44 mm | 47.18 mm |
| | | Compatibility with the<br>die and cast materials | | Reproduced for<br>0.05 mm | Reproduced for<br>0.05 mm | Reproduced for 0.05 mm |
| | | Curve of the shrinkage | | 9.98% | 4.20% | 10.79% |
| | | Viscosity | Base | 45,333mPas | 44,000mPas | 39,375mPas |
| | | | Catalyst | 59,000mPas | 55,050mPas | 23,125mPas |
| | Chemical<br>composition | Vinyl terminated group | | Vinyl siloxanes | | Polydimethylsiloxane polymer |
| | | Filler | | Silica, Fumed silica | | Silicon Dioxide,<br>Sodium Aluminosilicate |
| | | Cross linker | | Hydrogen polysiloxane | | Polymethyl hydrogen siloxane |
| | | Catalyst | | Organo platinum complex | | Organic platinum complex |
| | | Colorant | | Pigments | | Pigments |
| | | Surfactant | | Surfactant | | Surfactant |
| | | Standard Conformed | | ISO4823 | | ISO4823 |
| | | Biocompatibility | | Yes | | Yes |
| | | Use | | Prescription / Hospital | | Prescription / Hospital |
| Difference | Physical<br>properties | Color | | - Light red(Light red/White)<br>- Light orange(Light orange/White)<br>- Orange(Orange/White)<br>- Purple(Purple/White) | | - Orange<br>(Orange/White) |

Vonflex STM I iaht XI V

Vonflex S™ Light XLV is composed to Vinyl terminated group, Filler, Cross linker, Catalyst, Colorant and Surfactant as the predicate device. Many kinds of filler is used as a thickening agent in the impression materials. In general, Silica is synonym for silicon dioxide. So, The chemical composition of Vonflex S™ Light XLV is equivalent to the predicate device, Aquasil Ultra XLV Smart Wetting impression Material. Indication for use of Vonflex S™ Light XLV provide more detailed information than the predicate device for the user to have a better understanding of what Vonflex S™ Light XLV is indicated for. Through above table, most physical properties, Indications for use and chemical composition of Vonflex S™ Light XLV is similar to these of the predicate device.

The difference between Vonflex S™ Light XLV and predicate device is the color. But it doesn't affect to safety and effectiveness of product considerably. The two components of impression materials are requested contrasting colors to check the mixing condition, and the mixture should be distinguished from the oral tissue and blood. In this connection, the colors of Vonflex S™ Light XLV and predicate devices are satisfied these conditions.

Image /page/8/Picture/7 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. Biocompatibility
The biocompatibility evaluation for the Vonflex S™ was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1:Evaluation and Testing™ May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices -Part 1 : Evaluation and Testing Within a Risk Management Process" as recognized by FDA. The device of testing included the following tests:

- Cytotoxicity, ISO 10993-5[2009]
- Genotoxicity(Ames), ISO 10993-3[2003]
- Oral mucous Irritation, ISO 10993-10[2010]
- Sensitization(LLNA), ISO 10993-10[2010]

Vonflex S™ showed none cytotoxicity and none genotoxicity. Also it didn't show the irritation and sensitization response. So Vonflex S™ can be claimed to be biocompatible

- 8. Conclusions :
Most physical properties, instruction for use, chemical composition and etc. of Vonflex STM is similar to the predicate device. The difference between Vonflex S™ and predicate devices is the color. But it doesn't affect to performance of product considerably. Therefore, it is concluded that Vonflex S™ is substantially equivalent to the legally marketed predicate devices.

- 9. Vericom Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA.
Image /page/9/Picture/12 description: The image shows the logo for Vericom Dental Materials. The logo consists of the word "VERICOM" in white, bold, sans-serif font, set against a red, curved shape that resembles a smile. Below the red shape, the words "Dental materials" are written in a smaller, black, sans-serif font.