Admira Fusion Flow

K153177 · Voco GmbH · EBF · Jun 30, 2016 · Dental

Device Facts

• Record ID: K153177
• Device Name: Admira Fusion Flow
• Applicant: Voco GmbH
• Product Code: EBF · Dental
• Decision Date: Jun 30, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Admira Fusion Flow is intended for use as: - Filling of small cavities and extended fissure sealing - Blocking out undercuts - Lining or coating cavities - Fillings of class III V cavities - Repairing fillings, veneers and temporary restorations - Luting translucent prosthetic pieces - Locking, splinting of loose teeth

Device Story

Admira Fusion Flow is a light-cured, radiopaque, flowable restorative material based on ORMOCER (Organically Modified Ceramic) technology. Used by dental professionals in clinical settings for restorative procedures including cavity filling, fissure sealing, and splinting. The material is applied directly into the prepared dental site and cured using a dental curing light. It functions as a restorative resin to replace tooth structure or stabilize teeth. Benefits include improved aesthetics and structural support for damaged or decayed teeth.

Clinical Evidence

Bench testing only. Testing included physical and mechanical property evaluations (e.g., flexural strength, depth of cure, water sorption, solubility, and radiopacity) to demonstrate equivalence to the predicate device.

Technological Characteristics

Flowable, light-cured, radiopaque restorative material based on ORMOCER (Organically Modified Ceramic) technology. Supplied in syringe form for direct application. Polymerization initiated via external dental curing light. Class II device under 21 CFR 872.3690.

Indications for Use

Indicated for dental patients requiring restoration of small cavities, fissure sealing, undercut blocking, cavity lining/coating, Class III-V cavity fillings, repair of restorations/veneers, luting of translucent prosthetics, and splinting of loose teeth.

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 Flow (K032656)

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

June 30, 2016

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

Re: K153177

Trade/Device Name: Admira Fusion Flow Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: May 25, 2016 Received: May 27, 2016

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. 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

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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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## Indications for Use Statement

K153177 510(k) Number:

Device Name:

Indications for Use:

Admira Fusion Flow is intended for use as:

- Filling of small cavities and extended fissure sealing
- Blocking out undercuts

- Lining or coating cavities
- Fillings of class III V cavities
- Repairing fillings, veneers and temporary restorations
- Luting translucent prosthetic pieces
- Locking, splinting of loose teeth

Prescription Use

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)