VisCalor bulk

K190453 · Voco GmbH · EBF · Apr 11, 2019 · Dental

Device Facts

• Record ID: K190453
• Device Name: VisCalor bulk
• Applicant: Voco GmbH
• Product Code: EBF · Dental
• Decision Date: Apr 11, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Class I and II posterior restorations Base in class I and II cavities Class V restorations Locking, splinting of loose teeth Repairing veneers, enamel defects and temporary C&B-materials Extended fissure sealing Restoration of deciduous teeth Core build-up

Device Story

VisCalor bulk is a light-curing, radiopaque, thermoviscous restorative material. It is used by dental professionals in clinical settings for direct restorative procedures. The material is designed to be applied into tooth cavities; it transitions from a more viscous state to a flowable state upon heating, facilitating adaptation to cavity walls, then returns to a sculptable consistency upon cooling. It functions as a restorative resin to replace lost tooth structure or stabilize teeth. Benefits include improved handling and adaptation during placement, reducing the need for multiple layers in deep cavities. It is a manual restorative tool; no digital processing or software is involved.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Thermoviscous, light-curing, radiopaque resin-based composite. Material properties allow for viscosity reduction via heating for improved flow and adaptation, followed by rapid hardening upon cooling. Form factor: bulk-fill restorative material. Sterilization: not applicable (non-sterile dental material).

Indications for Use

Indicated for patients requiring dental restorations, including Class I and II posterior restorations, Class V restorations, base placement, tooth splinting, repair of veneers/enamel defects/temporary C&B materials, fissure sealing, deciduous tooth restoration, and core build-up.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Predicate Devices

• Admira Fusion x-tra (K152636)

Submission Summary (Full Text)

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## Indications for Use Statement

K190453 510(k) Number:

Device Name: VisCalor bulk

Indications for Use:

- Class I and II posterior restorations

- Base in class I and II cavities
- Class V restorations
- Locking, splinting of loose teeth
- Repairing veneers, enamel defects and temporary C&B-materials
- Extended fissure sealing
- Restoration of deciduous teeth
- Core build-up

Prescription Use __ X

OR

Over-The-Counter Use

(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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VOCO GmbH T. Gerkensmeier Regulatory Affairs Anton-Flettner-Str. 1-3 Cuxhaven, 27472 GERMANY

Re: K190453

Trade/Device Name: VisCalor Bulk Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: March 15, 2019 Received: March 27, 2019

Dear T. Gerkensmeier:

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. 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 located 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.

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 803) for

April 11, 2019

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For 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