VITIQUE SYSTEM

K023649 · Dmg USA, Inc. · EMA · Jan 17, 2003 · Dental

Device Facts

• Record ID: K023649
• Device Name: VITIQUE SYSTEM
• Applicant: Dmg USA, Inc.
• Product Code: EMA · Dental
• Decision Date: Jan 17, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3275
• Device Class: Class 2

Intended Use

The Vitique System is intended for use in permanent luting of definitive restorations of all kinds (metal, ceramic, composite), including veneers, crowns and bridges, onlays, telescopic crowns, attachments, pins and posts, orthodontic appliances, luting of ornaments, splinting etc. as well as a add-on for resin based materials. The Try-in pastes may also be used as a general water soluble separating agent (e.g. isolating material for use with prefabricated crowns, retraction cords etc.) or as an oxyguard gel.

Device Story

Vitique System is a dental luting kit comprising aesthetic cement, shade-matched Try-In pastes, silanating agent, and bonding system (etching gel/bonding agent). Used by dental professionals in clinical settings for permanent cementation of various dental restorations (metal, ceramic, composite). Try-In pastes allow clinicians to preview final restoration aesthetics before permanent bonding. Silanating agent prepares ceramic surfaces; bonding system facilitates adhesion to tooth structure. System provides aesthetic luting and restorative support; benefits include improved final restoration appearance and reliable cementation.

Clinical Evidence

Bench testing only. Conformity to ISO 4049 standards for polymer-based luting materials provided to demonstrate safety and performance.

Technological Characteristics

Polymer-based luting cement, silanating agent, and bonding system. Materials conform to ISO 4049 standards for polymer-based filling, restorative, and luting materials. System includes shade-matched Try-In pastes and etching components.

Indications for Use

Indicated for permanent luting of definitive dental restorations including metal, ceramic, and composite veneers, crowns, bridges, onlays, telescopic crowns, attachments, pins, posts, and orthodontic appliances; also for luting ornaments, splinting, and as an add-on for resin-based materials. Try-in pastes indicated as water-soluble separating agents or oxyguard gels.

Regulatory Classification

Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Predicate Devices

• Variolink II (K971372)
• Nexus (K972858)
• Panavia F (Unknown)
• Calibra (Unknown)
• Rely X (K022476)
• Vitremer (K933139)
• Principle (Unknown)
• ProTec Cem (K980922)

Submission Summary (Full Text)

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K023649

C MG USA Inc. A bbreviated 510(k) Premarket Notification

# 510(k) Summary

| Trade Name: | Vitique System | | JAN 17 2003 |
|----------------------|-----------------------------------------------------------------------------------------------------------------|--|-------------|
| Sponsor: | DMG USA, Inc.<br>414 South State Street<br>Dover, DE 19901<br>Registration # not yet assigned | | |
| Device Generic Name: | Dental luting material | | |
| Classification: | According to Section 513 of the Federal Food, Drug, and<br>Cosmetic Act, the device classification is Class II. | | |

### ?redicate Devices:

| Product Name | 510(k) # | Manufacturer |
|--------------|----------|--------------|
| Variolink II | K971372 | Vivadent |
| Nexus | K972858 | Kerr |
| Panavia F | Unknown | Kuraray |
| Calibra | Unknown | Dentsply |
| Rely X | K022476 | 3M |
| Vitremer | K933139 | 3M |
| Principle | Unknown | Dentsply |
| ProTec Cem | K980922 | Vivadent |

### Product Description:

The Vitique System consists of:

- Vitique Cement a highly aesthetic luting cement in various shades; .
- Try-In Pastes that precisely match the corresponding cement shade to approximate the final . result:
- Silanating agent for use in preparing ceramic surfaces for bonding; and ●
- Contax Bonding System a bonding system (etching gel, bonding system) for final bonding to ● tooth structure.

### Indications for Use:

The Vitique System is intended for use in permanent luting of definitive restorations of all kinds (metal, ceramic, composite), including veneers, crowns and bridges, onlays, telescopic crowns, attachments, pins and posts, orthodontic appliances, luting of ornaments, splinting etc. as well as a add-on for resin based materials. The Try-in pastes may also be used as a general water soluble separating agent (e.g. isolating material for use with prefabricated crowns, retraction cords etc.) or as an oxyguard gel.

### Safety and Performance:

This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), DMG USA, Inc. has provided information to demonstrate conformity with FDA's guidance document entitled Dental Cements - Premarket Notification, August 1998 and ISO 4049 - Dentistry - Polymer-based filling, restorative and luting materials.

### Conclusion:

Based on their indications for use, technological characteristics, and comparison to predicate devices, the Vitique System materials have been shown to be safe and effective for their intended use.

200058

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Image /page/1/Picture/1 description: The image is a black and white 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. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, but it is also designed to incorporate human profiles. The symbol is composed of three stylized profiles facing to the right, with flowing lines that suggest movement or flight.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2003

DMG USA, Incorporated C/O Ms. Pamela Papineau Delphi Medical Consulting, Incorporated 5 Whitcomb Avenue Ayer, Massachusetts 01432

Re: K023649 Trade/Device Name: Vitique System Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA

> Dated: October 18, 2002 Received: October 30, 2002

Dear Ms. Papineau:

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 - Ms. Papineau

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 (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.

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]. Additionally, for questions on the promotion and advertising of your device, 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 vour responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Page of

510(k) Number (if known): K023649

Device Name: _ Vitique System

Indications for Use:

The Vitique System consists of a highly aesthetic luting cement in various shades, Try-In pastes that precisely match the corresponding cement shade to approximate the final result, a silanating agent to prepare ceramic surfaces for bonding, and a bonding system (etching gel, bonding system) for bonding to tooth structure.

The Vitique System is intended for use in permanent luting of definitive restorations of all kinds (metal, ceramic, composite), including veneers, crowns and bridges, onlays, telescopic crowns, attachments, pins and posts, orthodontic appliances, luting of ornaments, splinting etc. as well as a add-on for resin based materials

The Try-in pastes may also be used as a general water soluble separating agent (e.g. isolating material for use with prefabricated crowns, retraction cords etc.) or as an oxyquard gel.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | |
|---------------------------------------|--|
|---------------------------------------|--|

OR

| Over-the -Counter Use | |
|-----------------------|--|
|-----------------------|--|

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

| 510(k) Number: | |
|----------------|--|
|----------------|--|

000008