VONFLEX S BITE

K140966 · Vericom Co., Ltd. · ELW · Aug 15, 2014 · Dental

Device Facts

• Record ID: K140966
• Device Name: VONFLEX S BITE
• Applicant: Vericom Co., Ltd.
• Product Code: ELW · Dental
• Decision Date: Aug 15, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

Standard bite registrations in the end bite position - Portrayal of antagonists - Coating of bite forks - Key material for needle point registration - -Production of small model segments

Device Story

Vonflex™ S Bite is a dental impression material used by dental professionals for bite registration and model segment production. It functions as a physical material applied to bite forks or dental structures to capture accurate occlusal relationships. The material sets to provide a stable, accurate record of the patient's bite, which the clinician uses to facilitate restorative or diagnostic dental procedures. It serves as a clinical tool for dental practitioners to ensure proper alignment and fit of dental prosthetics or appliances.

Clinical Evidence

Bench testing only.

Technological Characteristics

Impression material (Product Code ELW). Class II device per 21 CFR 872.3660. Physical material properties consistent with standard dental impression materials.

Indications for Use

Indicated for dental professionals performing standard bite registrations, portraying antagonists, coating bite forks, needle point registration, and producing small model segments.

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).

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

August 15, 2014

VERICOM Co., Ltd. Mr. Myung-Hwan Oh R&D Director 48 Toegyegongdan 1- Gil Chuncheon- Si, Gangwon-Do Republic of Korea 430-817

Re: K140966

Trade/Device Name: Vonflex™ S Bite Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: May 8, 2014 Received: May 23, 2014

## Dear Mr. 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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Page 2 - Mr. Oh

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

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

Device Name: Vonflex™ S Bite

Indication for use:

- Standard bite registrations in the end bite position -
- Portrayal of antagonists -
- Coating of bite forks -
- Key material for needle point registration -
- -Production of small model segments

| Prescription Use | | OR |
|------------------------|--|----|
| (Per 21 CFR Subpart D) | | |

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)