AMARIS GINGIVA OPAQUER

K090843 · Voco GmbH · EBF · Jun 17, 2009 · Dental

Device Facts

• Record ID: K090843
• Device Name: AMARIS GINGIVA OPAQUER
• Applicant: Voco GmbH
• Product Code: EBF · Dental
• Decision Date: Jun 17, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Amaris® Gingiva Opaquer is intended for use in conjunction with Amaris Gingiva for the following applications: - for the aesthetic covering and masking of discoloured hypersensitive necks of teeth, especially in the visible anterior area. - for corrections of the red-white aesthetics. - for masking and lightening of crown and bridge restorations and margins.

Device Story

Amaris® Gingiva Opaquer is a light-curing, radiopaque restorative material used in dentistry. It is applied by dental professionals to treat cervical defects, mask discolored or hypersensitive tooth necks, and correct gingival aesthetics (red-white aesthetics) in the anterior region. The device is used in conjunction with Amaris® Gingiva restorative material. It functions as an opaquer to mask underlying tooth or restoration structures, improving aesthetic outcomes. It is cured using blue light. The device is intended for prescription use in a clinical setting.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Light-curing, radiopaque restorative material; contains 80% fillers in a methacrylate matrix; cured via blue light. Components are identical to those in the predicate device (Clearfil ST Opaquer).

Indications for Use

Indicated for patients requiring aesthetic restoration of discolored or hypersensitive tooth necks, correction of red-white aesthetics, or masking/lightening of crown and bridge restorations and margins in the anterior region.

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

• Clearfil ST Opaquer/Kuraray Co. Ltd. (K001913)

Submission Summary (Full Text)

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## 510(k) SUMMARY

| Contact: | Manfred Plaumann | |
|----------------------------|-----------------------------------------------|-------------|
| Date prepared: | March 25th, 2009 | JUN 17 2009 |
| Trade or proprietary name: | Amaris® Gingiva | |
| Classification name: | Material, Tooth Shade, Resin (872.3690) | |
| Predicate device: | Clearfil ST Opaquer/Kuraray Co. Ltd., K001913 | |

Device description: Amaris® gingival shade is a light-curing radiopaque restorative which contains 80% fillers in a methacrylate matrix and which can be cured with blue light. Amaris® gingival shade is used to treat cervical defects and exposed, discoloured or hypersensitive necks of teeth, especially in the visible anterior area. The gingival-like shade and the Amaris® Gingiva Opaquer system allow the correct reproduction of the gingiva in its shade.

#### Intended use:

Amaris® Gingiva Opaquer is intended for use in conjunction with Amaris Gingiva for the following applications:

- for the aesthetic covering and masking of discoloured hypersensitive necks of teeth, ເ especially in the visible anterior area.
- for corrections of the red-white aesthetics.
- for masking and lightening of crown and bridge restorations and margins. -

Technological characteristics: All of the components of Amaris® Gingiva Opaquer are found in the legally marketed device Clearfil ST Opaquer/Kuraray Co. Ltd., K001913.

The prior use of all of the components of Amaris® Gingiva Opaquer in legally marketed devices supports our decision that additional testing for cytotoxicity and mutagenicity as well as additional biocompatibility studies with the final formulation are not necessary. We believe that the prior use of the components of Amaris® Gingiva Opaquer in legally marketed devices and the performance data and results provided support the safety and effectiveness of Amaris® Gingiva Opaquer for the intended use.

VOCO GmbH, March 25th, 2009

VOCO GMBH
Anton Flettner-Str. 1-3
Manfred Plaumann
27472 CUXHAVEN
Managing Board
Germany

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three legs and a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged around the top half of the circular border.

# JUN 17 2009

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. T. Gerkensmeier Regulatory Affairs VOCO GmbH Anton-Flettner-Strasse 1-3 D-27472 Cuxhaven GERMANY

Re: K090843

Trade/Device Name: Amaris Gingiva Opaquer Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: June 3, 2009 Received: June 9, 2009

Dear Dr. 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.

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 - Dr. Gerkensmeier

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Susan Keane

Susan Runner, D.D.S., M.A Acting 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: K690843

Amaris® Gingiva Opaquer Device Name:

Indications for Use:

Amaris® Gingiva Opaquer is intended for use in conjunction with Amaris Gingiva for the following applications:

- for the aesthetic covering and masking of discoloured hypersensitive necks of teeth, especially in the visible anterior area.
- for corrections of the red-white aesthetics.
- for masking and lightening of crown and bridge restorations and margins.

**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)

Rin Muluy Fri MSR

(Division-Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K090843