LUXAFORM PLUS

K033227 · Dmg USA, Inc. · EBG · Jan 16, 2004 · Dental

Device Facts

• Record ID: K033227
• Device Name: LUXAFORM PLUS
• Applicant: Dmg USA, Inc.
• Product Code: EBG · Dental
• Decision Date: Jan 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2

Intended Use

LuxaForm Plus is indicated for the following uses: - As a matrix in the fabrication of provisional dental crowns and bridges . - Mini "custom tray" for impressions . - . Articulation of diagnostic molds - Articulation of the working cast against the opposing arch . - For fabrication of a maxillary bite guard, a maxillary anterior or posterior . bite plate or a maxillary anterior repositioning appliance - Direct fabrication of Maxillary sports guard in the mouth without models ● - Bite registration material either to be used directly or in combination with . three way trays (e.g. Triple Trays from Premier) - Reinforcement of three way trays . - For use in functional therapeutic cases as e.g. a Lucia Jig, anterior . repositioning splint etc. - Guiding matrix to help recreate anatomic form .

Device Story

LuxaForm Plus is a quick-setting pre-impression matrix material used in dental clinics. It functions as a moldable resin for fabricating provisional crowns, bridges, bite registrations, and various oral appliances (e.g., sports guards, splints). The material is applied by a dental professional to capture anatomical form or create custom trays. It serves as a physical matrix or registration medium, aiding in the recreation of dental anatomy and the articulation of casts. It is used directly in the patient's mouth or in conjunction with dental trays. The device benefits patients by facilitating the efficient creation of temporary dental restorations and therapeutic appliances.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and comparison of chemical composition and performance specifications to predicate devices.

Technological Characteristics

Temporary crown and bridge resin material. Chemical composition includes components found in predicate dental resins and matrix materials. Form factor is a moldable matrix material for dental impressions and appliance fabrication. No electronic components or software.

Indications for Use

Indicated for dental patients requiring provisional crown/bridge fabrication, impression taking, bite registration, diagnostic mold articulation, or fabrication of oral appliances including bite guards, bite plates, repositioning splints, and sports guards.

Regulatory Classification

Identification

A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

Predicate Devices

• LuxaForm (K000951)
• Advantage Dental Products Temporary Crown Matrix Buttons (K900389)
• Heraeus Kulzer Paladur dental resin material (K915898)

Submission Summary (Full Text)

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JAN 1 6 2004

# 510(k) Summary

#### LuxaForm Plus Trade Name:

Sponsor: DMG USA, Inc. 414 South State Street Dover, DE 19901 Registration # not yet assigned Owner/Operator #9005969

#### Device Generic Name:

Temporary Crown and Bridge Resin Material

#### Classification:

According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II.

### Predicate Devices:

The proposed LuxaForm Plus is substantially equivalent to the currently marketed DMG USA LuxaForm material, which was cleared for marketing bv FDA in K000951. In addition, the chemical composition of the LuxaForm Plus material includes materials found in both the Advantage Dental Products Temporary Crown Matrix Buttons as cleared in K900389 and the Heraeus Kulzer Paladur dental resin material, which was cleared in K915898.

#### Product Description:

The LuxaForm Plus is a detailed quick pre-impression matrix used in the fabrication of provisional crowns and bridges and can also be used as a bite registration material.

#### Indications for Use:

LuxaForm Plus is indicated for several uses:

- As a matrix in the fabrication of provisional dental crowns and bridges .
- Mini "custom tray" for impressions .
- Articulation of diagnostic molds .
- Articulation of the working cast against the opposing arch .
- For fabrication of a maxillary bite guard, a maxillary anterior or posterior . bite plate or a maxillary anterior repositioning appliance
- Direct fabrication of Maxillary sports guard in the mouth without models .

Confidential - This file contains proprietary, trade secret information which is the property of DMG USA and DMG Hamburg. This information may only be disclosed to or viewed by authorized (in writing) representatives of DMG, Delphi Medical Device Consulting, and the U.S. Food and Drug Administration.

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- Bite registration material either to be used directly or in combination with . three way trays (e.g. Triple Trays from Premier)
- Reinforcement of three way trays .
- For use in functional therapeutic cases as e.g. a Lucia Jig, anterior . repositioning splint etc.
- Guiding matrix to help recreate anatomic form .

## Safety and Performance:

Substantial equivalence for this device was based on similarities in design, chemical composition and performance specifications as compared to predicate materials. The materials, performance specifications and essential design characteristics of the LuxaForm Plus are identical to those of the predicate devices.

### Conclusion:

Based on the indications for use, technological characteristics, and comparison to predicate devices, the LuxaForm Plus has been shown to be safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 6 2004

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

Re: K033227

Trade/Device Name: Luxaform Plus Regulation Number: 872-3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: December 31, 2003 Received: January 7, 2004

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 (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 responsibilitics 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/dsma/dsmamain.html

Sincerely yours,

Chih-Lin, Ph.D.

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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Page

510(k) Number (if known):

Device Name: LuxaForm Plus____________________________________________________________________________________________________________________________________________________

Indications for Use:

LuxaForm Plus is indicated for the following uses:

- As a matrix in the fabrication of provisional dental crowns and bridges .
- Mini "custom tray" for impressions .
- . Articulation of diagnostic molds
- Articulation of the working cast against the opposing arch .
- For fabrication of a maxillary bite guard, a maxillary anterior or posterior . bite plate or a maxillary anterior repositioning appliance
- Direct fabrication of Maxillary sports guard in the mouth without models ●
- Bite registration material either to be used directly or in combination with . three way trays (e.g. Triple Trays from Premier)
- Reinforcement of three way trays .
- For use in functional therapeutic cases as e.g. a Lucia Jig, anterior . repositioning splint etc.
- Guiding matrix to help recreate anatomic form .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|---------------------------------------------|--|
| Division of Anesthesiology, General Hospita | |
| Infection Control, Dental Devices | |
| 510(k) Number: | |

| Prescription Use ✓ (Per 21 CFR 801.109) | OR Over-the -Counter Use |
|-----------------------------------------|--------------------------|
|-----------------------------------------|--------------------------|

| (Division Sign-Off) | Susan Runser |
|-----------------------------------------------|--------------|
| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K033227 |

Confidential - This file contains proprietary, trade secret information which is the property of DMG USA and DMG Hamburg. This information may only be disclosed to or viewed by authorized (in writing) representatives of DMG, Delphi Medical Device Consulting, and the U.S. Food and Drug Administration.