Admira Fusion x-base

K170896 · Voco GmbH · EBF · Jun 29, 2017 · Dental

Device Facts

• Record ID: K170896
• Device Name: Admira Fusion x-base
• Applicant: Voco GmbH
• Product Code: EBF · Dental
• Decision Date: Jun 29, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Base in class I and II cavities; Cavity lining under direct restorative materials in class I and II cavities; Small, non occlusal stress-bearing class I restorations according to minimally invasive filling therapy; Class III and V restorations; Extended fissure sealing; Undercut blockout; Repair of small enamel defects; Repair of small defects in aesthetic indirect restorations; Repair of temporary C&B-materials; Core build-up

Device Story

Admira Fusion x-base is a light-cured, radiopaque, flowable, ormocer-based (organically modified ceramic) restorative material. Used by dental professionals in clinical settings for cavity lining, base placement, small restorations, and repairs. Applied directly into the prepared tooth cavity or defect site; cured using a dental curing light. Provides structural support, cavity sealing, and aesthetic repair. Benefits include minimally invasive treatment options and versatility in restorative procedures.

Clinical Evidence

Bench testing only. Performance data included physical and chemical property testing, biocompatibility, and radiopacity assessments to demonstrate substantial equivalence to the predicate device.

Technological Characteristics

Ormocer-based (organically modified ceramic) restorative material. Light-cured. Radiopaque. Flowable consistency. Supplied in syringe form factor. No electronic components or software.

Indications for Use

Indicated for use as a dental restorative material for base/lining in class I and II cavities, small non-occlusal class I restorations, class III and V restorations, fissure sealing, undercut blockout, and repair of small enamel/aesthetic indirect restoration/temporary C&B defects, 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 (K150061)

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 29, 2017

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

Re: K170896

Trade/Device Name: Admira Fusion x-base Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: April 10, 2017 Received: April 12, 2017

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

Image /page/0/Picture/11 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.

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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.

## Andrew I. Steen -S

for Lori A. Wiggins, MPT, CLT 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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## Indications for Use Statement

K170896 510(k) Number:

Device Name: Admira Fusion x-base

Indications for Use:

- Base in class I and II cavities ।
- Cavity lining under direct restorative materials in class I and II cavities i
- l Small, non occlusal stress-bearing class I restorations according to minimally invasive filling therapy
- Class III and V restorations i
- Extended fissure sealing l
- Undercut blockout l
- -Repair of small enamel defects
- Repair of small defects in aesthetic indirect restorations -
- Repair of temporary C&B-materials -
- 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)