X-TRA FIL

K053391 · Voco GmbH · EBF · Feb 15, 2006 · Dental

Device Facts

• Record ID: K053391
• Device Name: X-TRA FIL
• Applicant: Voco GmbH
• Product Code: EBF · Dental
• Decision Date: Feb 15, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

x-tra fil is indicated for posterior Class I and Class II cavities and core build-up.

Device Story

x-tra fil is a hybrid resin composite restorative material; used for filling posterior dental cavities and core build-up. Device consists of a single paste; applied by dental professionals in a clinical setting. Material is cured using visible/blue light. Output is a hardened dental restoration. Benefits include structural repair of posterior teeth.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Hybrid resin composite restorative material. Single paste formulation. Visible/blue light cured. Components are identical to those used in previously cleared dental restorative devices.

Indications for Use

Indicated for patients requiring restoration of posterior Class I and Class II cavities 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

• Quixx Posterior Restorative (K040144)

Reference Devices

• K994056
• K926458
• K040769
• K030914
• K912425

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the word "VOCO" in a stylized font. Above the word is the text "K053391, jp/1951". The letters of the word "VOCO" are represented by geometric shapes. The "V" is an upside-down triangle with a rectangle cut out of the top, the "O" is a circle with a smaller circle cut out of the center, the "C" is a circle with a wedge cut out of it, and the last "O" is a circle with a smaller circle cut out of the center.

1

FEB 1 5 2006

| | VOCO GmbH · Postfach 7 67 · 27457 Cuxhaven · Germany | | | | Anton-Flettner-Straße 1 - 3<br>27472 Cuxhaven · Germany | |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|---------------|--|---------------------------------------------------------|----------------|
| | | | | | | [phone] |
| | | | | | 04721 719-109<br>[phone] | |
| | | | | | www.voco.de<br>[e-mail] | |
| | | | | | | |
| Ihr Zeichen<br>yr ref. | Ihre Nachricht vom<br>dtd. | Unser Zeichen<br>our ref. | Datum<br>date | | | |
| | 510(k) SUMMARY | | | | | |
| Contact: | Dr. Süs | | | | | |
| Date prepared: | November 29, 2005 | | | | | |
| Trade or<br>proprietary name: | x-tra fil | | | | | |
| Classification name: | Tooth shade resin material (872.3690) | | | | | |
| Predicate device: | Quixx Posterior Restorative K 040144 | | | | | |
| Device description: | x-tra fil is a hybrid resin composite restorative material for use in filling posterior dental cavities. The restorative consists of a single paste that is visible/blue light cured. | | | | | |
| Intended use: | x-tra fil is indicated for posterior Class I and Class II cavities and core build-up. | | | | | |
| Technological<br>characteristics: | All of the components of x-tra fil are found in the legally marketed devices K 040144, K 994056, K 926458, K 040769, K 030914, K 912425. | | | | | |
| | The prior use of all of the components of x-tra fil in legally marketed devices support our | | | | | |

The prior use of all of the components of x-tra fil in legally marketed devices support 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 x-tra fil in legally marketed devices and the performance data and results provided support the safety and effectiveness of x-tra fil for the intended use.

VOCO GmbH, November 29, 2005

Dr. Michael Sus Mgr. for regulatory affairs

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three stripes representing its wings. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 5 2006

Dr. Michael Sus Manager Voco GmbH Anton-Flettner-Strasse 1-3 Cuxhaven, Germany D-27472

Re: K053391

KUJ3391
Trade/Device Name: x-tra fil is Intended for light curing Class I and class II Posterior Fillings and Core Build-up Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: November 29, 2005 Received: December 7, 2005

Dear Dr. Sus:

We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your bection 910(4) personally equivalent (for the referenced above and have determined and to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate collineree pror to may 20, 77 % a cordance with the provisions of Amendinens, of to devices that have ober (Act) that do not require approval of a premarket the rederal Pood, Drug, and Cosment Proc (Prov market the device, subject to the general approval application (1 Mill) - The general controls provisions of the Act include controls provisions of the Feat - the girling 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 If your device is classified (500 a0010) in a controls. Existing major regulations affecting (FMA), it may oc subject to backs and readers, Title 21, Parts 800 to 898. In your device can be found in the Sous of Concerning your device in the Ecderal Register.

{2}------------------------------------------------

## Page 2 - Dr. Sus

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that IDA S Issualled of a basetan requires with other requires mean that FDA has made a decemination until Js administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by other frequires in of the Act of any rederal statutes and regulations, but not limited to: registration
You must comply with all the Act's requirements, including progrises You must comply with an the Act 3 requirement 801); good manufacturing practice and listing (21 CFR Fall 807), labeling (21 CFR rate 77 //
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 821, 542 // 1ha requirements as set form in the quality Systems (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 5 (0(k) This letter will antw you to begin matically your device of your device to a premarket nothreation. The PDA miding of basically of 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 CH'R Part 801), If you desire specific advice for your de at [phone]. Also, please note the regulation
Please contact the Office of Compliance at [phone]. Also, please note presse contact une Office or Comphanos are (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Binar-2041 or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Runne

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

{3}------------------------------------------------

## Indications for Use Statement

510(k) Number: K053391

Device Name: x-tra fil___

Indications for Use:

x-tra fil is intended for light curing class I and class II posterior fillings and core build-up.

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)

Susan Cuomo

Division of Anesthesiology, General Hospital,
fection Control, Dental Devices
21000 Number 2/15/04