(88 days)
It is used for all crown, bridge and orthodontic impression techniques.
Vonflex S™ 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.
This is a 510(k) premarket notification for a dental impression material, Vonflex S™ Putty, and not an AI or software device. Therefore, many of the requested categories related to AI/software performance, such as sample sizes for test/training sets, ground truth establishment for AI, MRMC studies, and AI-specific acceptance criteria, are not applicable to this document.
The acceptance criteria and performance data presented here are for the physical and biological properties of a dental material.
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (ISO 4823) | Reported Device Performance (Vonflex S™ Putty) |
|---|---|
| Physical Properties: | |
| Classification according to ISO4823 | Type 0 |
| Dimensional accuracy: Max. 1.5% | Max. 1.5% |
| Consistency: Max. 35mm | Max. 35mm |
| Compatibility with the die and cast materials: 75μm reproduction | 75μm reproduction |
| Curve of the shrinkage (Strain in compression): Min. 0.8% ~ Max. 20% | Min. 0.8% ~ Max. 20% |
| Biocompatibility Tests (ISO 10993): | |
| Cytotoxicity (ISO 10993-5) | Passed (Biocompatible for intended use) |
| Sensitization and Irritation (ISO 10993-10) | Passed (Biocompatible for intended use) |
| In vitro genotoxicity (Ames test) (ISO 10993-3) | Passed (Biocompatible for intended use) |
2. Sample sized used for the test set and the data provenance:
This document describes performance testing for a dental impression material. The specific sample sizes for each physical property test are not detailed in this summary. The data provenance is Vericom Co., Ltd., Republic of Korea, as they conducted the tests (prospective in the context of this submission).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is for performance testing of a physical material, not for a diagnostic device requiring expert interpretation or ground truth establishment in the typical AI/software sense. The "ground truth" for these tests are the defined standards within ISO 4823 and ISO 10993.
4. Adjudication method for the test set:
Not applicable. This is for performance testing of a physical material, not for a diagnostic device with human interpretation.
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:
Not applicable. This is not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI-powered device.
7. The type of ground truth used:
For physical properties, the "ground truth" is defined by the requirements and test methods specified in the international standard ISO 4823 (Dentistry - Elastomeric impression materials). For biocompatibility, the "ground truth" is based on the safety endpoints and test methods specified in ISO 10993 (Biological evaluation of medical devices).
8. The sample size for the training set:
Not applicable. This is not an AI-powered device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI-powered device that requires a training set or its associated ground truth establishment.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
-
- Company making the submission:
| Submitter | |
|---|---|
| Name | VERICOM Co., Ltd. |
| Address | 48, Toegyegongdan 1-Gil,Chuncheon-Si, Gangwon-Do,Republic of Korea 200-944 |
| Phone | +82 31 441-2881 |
| Fax | +82 31 441-2883 |
| Contact | Myung-Hwan Ohomh@vericom.co.kr |
| Internet | www.vericom.co.kr |
2. Device:
Proprietary Name - Vonflex STM Putty Common Name - Impression Materials Classification Name - Material, Impression
-
- Predicate Device:
Delikit Putty, Sherpa Korea, K103346
- Predicate Device:
-
- 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.
- Description:
-
- Indication for use:
It is used for all crown, bridge and orthodontic impression techniques.
- Indication for use:
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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-
- 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.
- Technological Characteristics and Performance Testing:
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)Number | N/A | K103346 | - |
| Proprietaryname | Vonflex S™ Putty | Delikit Putty | - |
| Manufacturer | VERICOM CO., LTD. | Sherpa Korea | |
| Indicationsfor use | It is used for all crown,bridge and orthodonticimpression techniques. | It is an addition-curevinyl polysiloxane dentalimpression material that isused for all crown andbridge, edentulous,orthodontic and implantimpression techniques. | The indication for useof the subject andpredicate device is tomake impressiontaking, but it is notlimited to theapplications listed inthe indications foruse. |
| Standardconformed | ISO4823 | ISO4823 | Claims are the same |
| Physicalproperties | - Classification according toISO4823: Type 0- Dimensional accuracy:Max.1.5%- Consistency: Max. 35mm- Compatibility with the dieand cast materials:75μm reproduction- Curve of the shrinkage(Strain in compression):Min.0.8 ~ Max.20% | - Classification accordingto ISO4823: Type 0- Dimensional accuracy:Max. 1.5%- Consistency: Max.35mm- Compatibility with the dieand cast materials:75μm reproduction- Curve of the shrinkage(Strain in compression):Min.0.8 ~ Max.20% | The classification ofthe subject andpredicate device iscomplied with ISO4823 (Type 0).According to thedescription andbench test result, thephysical properties ofthe subjectivedevices are similar tothese of thepredicate device. |
| Raw Material | Vinyl polysiloxane | Vinyl polysiloxane | Claims are the same |
| Mixing Ratio | 1:1 | 1:1 | Claims are the same |
| Method ofManipulation | 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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-
- 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.
- Conclusions :
-
- Vericom Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA.
END
- Vericom Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA.
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.
§ 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).