LUXABITE

K013236 · Dmg USA, Inc. · ELW · Oct 17, 2001 · Dental

Device Facts

• Record ID: K013236
• Device Name: LUXABITE
• Applicant: Dmg USA, Inc.
• Product Code: ELW · Dental
• Decision Date: Oct 17, 2001
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

LuxaBite is indicated for use as a bite registration material for use in the production of crowns, bridges and dentures, and in orthodontic treatments. It may also be used as a provisional crown & bridge material.

Device Story

LuxaBite is a dental bite registration material composed of glass fillers in a multifunctional methacrylate matrix. Provided in automixing cartridges for direct intraoral dispensing. Material features 45-second working time; sets to firm consistency with slight elasticity within 2.5 minutes. Used by dental professionals in clinical settings for crown, bridge, denture, and orthodontic procedures. Acts as a physical impression medium to capture occlusal relationships; aids in fabrication of dental prosthetics and provisional restorations.

Clinical Evidence

No clinical data. Substantial equivalence was based solely on design and technical specifications.

Technological Characteristics

Composition: glass fillers in a matrix of multifunctional methacrylates. Form factor: automixing cartridges. Setting mechanism: chemical cure. Consistency: firm with slight elasticity.

Indications for Use

Indicated for use as a bite registration material in the production of crowns, bridges, dentures, and orthodontic treatments; also indicated for use as a provisional crown and bridge material.

Regulatory Classification

Identification

Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

Special Controls

*Classification.* Class II (Special Controls).

Predicate Devices

• DMG LuxaTemp temporary crown and bridge material (K942830)

Submission Summary (Full Text)

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

# OCT 1 7 2001

## 510(k) Summary

| Trade Name: | LuxaBite |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | DMG USA, Inc.<br>414 South State Street<br>Dover, DE 19901<br>Registration # not yet assigned<br>Owner/Operator No. 9005969 |
| Device Generic<br>Name: | Dental bite registration material |
| Classification: | According to Section 513 of the Federal Food, Drug, and<br>Cosmetic Act, the device classification is Class II. |

#### Predicate Device:

The proposed DMG USA LuxaBite material is substantially equivalent to other currently marketed dental impression / bite registration materials and the DMG LuxaTemp temporary crown and bridge material K942830.

### Product Description:

The LuxaBite dental bite registration material is composed of glass fillers in a matrix of multifunctional methacrylates. This quick setting material is provided in automixing cartridges, and can be dispensed directly onto the teeth. The material has a total working time of 45 seconds. LuxaBite sets up to a firm consistency with a slight amount of elasticity, and may be removed from the teeth within 2-1/2 minutes.

### Indications for Use:

LuxaBite is indicated for use as a bite registration material for use in the production of crowns, bridges and dentures, and in orthodontic treatments. It may also be used as a provisional crown & bridge material.

### Safety and Performance:

Substantial equivalence for this device was based solely on design and technical specifications; no performance or safety data was included in this premarket notification. The materials, performance specifications and essential design characteristics of the LuxaBite material are equivalent to those of the predicate devices. The proposed LuxaBite material complies with FDA's 1998 guidance document: Dental Impression Materials - Premarket Notification.

### Conclusion:

Based on the indications for use, technological characteristics, and comparison to the predicate device, the LuxaBite material has been shown to be safe and effective for its intended use.

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

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

OCT 1 7 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K013236

Trade/Device Name: LuxAbite Regulation Number: 872.3660 Regulation Name: Dental Bite Registration Material Regulatory Class: II Product Code: ELW Dated: September 17, 2001 Received: September 28, 2001

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 mendments, 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 the rousean I 600 m Drag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions 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 (1 WI ), It may be back of Federal Regulations, Title 21, Parts 800 to 898. In Jour Co., 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 or any Federal statutes and regulations administered by other Federal agencies.

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

Page 2 - Ms. Papineau

You must comply with all the Act's requirements, including, but not limited to: registration I ou must comply with and are reseling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR rat 807), labsiting (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 This letter will anow you to organizations of substantial equivalence of your device to J10(x) premiered 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 If you dosire position FFS Part 809.10 for in vitro diagnostic devices), please contact the and additionally = 1 = 2 = 4613. Additionally, for questions on the promotion and Office of Collightance wice, please contact the Office of Compliance at [phone]. also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under notification (21 OF ICP at 2001 the Division of Small Manufacturers, International and the Net ind of occurities to 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

Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

September 17, 2001 LuxaBite

000008

1 of of 1 Page _

510(k) Number (if known): KQ13236

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

LuxaBite is indicated for use as a bite registration material for use in the production of crowns, bridges and dentures, and in orthodontic treatments. It may also be used as a provisional crown & bridge material.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-the -Counter Use **__**

Susan Punpe

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number **__**K013231