AMARIS/AMARIS FLOW

K071386 · Voco GmbH · EBF · Jun 5, 2007 · Dental

Device Facts

• Record ID: K071386
• Device Name: AMARIS/AMARIS FLOW
• Applicant: Voco GmbH
• Product Code: EBF · Dental
• Decision Date: Jun 5, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

AMARIS/AMARIS FLOW is a light curing, radiopaque composite filling material for both anterior and posterior applications.

Device Story

Amaris/Amaris Flow is a light-curing, radiopaque composite resin used by dental professionals for restorative procedures in anterior and posterior teeth. The material is applied to the tooth cavity and cured using a dental light-curing unit. It functions as a restorative filling material to replace lost tooth structure. The device is intended for prescription use in a clinical dental setting.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Light-curing, radiopaque composite resin. Formulated for anterior and posterior dental restorations. Class II device under 21 CFR 872.3690.

Indications for Use

Indicated for use as a light-curing, radiopaque composite filling material for restorative procedures in both anterior and posterior 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.

Submission Summary (Full Text)

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ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Mr. Manfred Thomas Plaumann Managing Board VOCO GmbH Anton-Flettner-StraBe 1 - 3 27472 Cuxhaven GERMANY

JUN - 5 2007

Re: K071386

Trade/Device Name: Amaris/Amaris Flow Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: May 16, 2007 Received: May 18, 2007

Dear Mr. Plaumann:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Plaumann

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Senite y. Michian Ows

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

## Enclosure

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## Indications for Use Statement

510(k) Number: _

Device Name: AMARIS/AMARIS FLOW

Indications for Use:

AMARIS/AMARIS FLOW is a light curing, radiopaque composite filling material for both anterior and posterior applications.

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)

Suza Runore

sion of Anesthesiology, eneral Hos Intection Control. Der

510(k) Number: 1071356