LUXATEMP ULTRA /STAR

K101710 · Dmg USA, Inc. · EBG · Sep 28, 2010 · Dental

Device Facts

• Record ID: K101710
• Device Name: LUXATEMP ULTRA /STAR
• Applicant: Dmg USA, Inc.
• Product Code: EBG · Dental
• Decision Date: Sep 28, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3770
• Device Class: Class 2

Intended Use

Luxatemp Ultra/Star is a self-curing or dual-curing composite for the fabrication of temporary crowns and bridges, inlays, onlays and veneers. Luxatemp Ultra/Star is intended for the fabrication of: - temporary crowns - bridges - inlays - onlays - long-term temporaries - temporary veneers . Luxatemp Ultra/Star is also indicated for incorporation of most mechanically anchored attachment components into the acrylic base of a denture, an overdenture or partial denture.

Device Story

Luxatemp Ultra/Star is a composite material used by dental professionals for fabricating temporary dental restorations (crowns, bridges, inlays, onlays, veneers) and for incorporating attachment components into denture bases. The device is supplied in two formulations: self-curing and dual-curing, packaged in Smartmix syringes or Automix cartridges. The dual-cure formulation includes a light-cure component to facilitate curing. Clinicians apply the material to create temporary structures, which are then cured to achieve the required physical properties. The material provides improved compressive and flexural strength compared to previous versions, benefiting patients by offering more durable and stable temporary restorations during the interim period before final prosthetic placement.

Clinical Evidence

Bench testing only. Performance testing compared the device to the predicate, evaluating compressive strength, flexural strength, tensile strength, hardness, water sorption, working time, and curing time. Compliance with ISO 7405:2008 (biocompatibility) and ISO 4049:2000 (polymer-based restorative materials) was demonstrated.

Technological Characteristics

Composite material; self-curing or dual-curing formulations. Supplied in Smartmix syringes or Automix cartridges. Complies with ISO 7405:2008 for biocompatibility and ISO 4049:2000 for polymer-based restorative materials. No electronic or software components.

Indications for Use

Indicated for fabrication of temporary crowns, bridges, inlays, onlays, long-term temporaries, and temporary veneers; also indicated for incorporation of mechanically anchored attachment components into acrylic bases of dentures, overdentures, or partial dentures.

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

• Luxatemp / Luxatemp Solar (K013674)

Submission Summary (Full Text)

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DMG USA, Inc. K101710/Amendment 1

17

August 16, 2010 Luxatemp Ultra/Star

| 510(k) Summary | |
|----------------------|-----------------------------------------------------------------------------------------------------------------|
| Trade Name: | Luxatemp Ultra/Star |
| Date Prepared: | August 16, 2010 |
| Sponsor: | DMG USA, Inc.<br>23 Frank Mossberg Drive<br>Attleboro, MA 02703 |
| | Owner/Operator No. 9005969 |
| Device Generic Name: | Temporary crown and bridge material |
| Classification: | According to Section 513 of the Federal Food, Drug, and<br>Cosmetic Act, the device classification is Class II. |
| Regulation: | 21 CFR 872.3770; Product Code EBG |

#### Indications for Use:

Luxatemp Ultra/Star is a self-curing or dual-curing composite for the fabrication of temporary crowns and bridges, inlays, onlays and veneers.

Luxatemp Ultra/Star is intended for the fabrication of:

- . temporary crowns
- . bridges
- . inlays
- . onlays
- long-term temporaries .
- temporary veneers .

Luxatemp Ultra/Star is also indicated for incorporation of most mechanically anchored attachment components into the acrylic base of a denture, an overdenture or partial denture.

#### Device Description:

Luxatemp Ultra/Star is a self-curing or dual-curing composite for the fabrication of temporary crowns and bridges, inlays, onlays and veneers. Luxatemp Ultra/Star will be supplied in 2 formulations; one is self-curing and the other is dual-cure. The 2 formulations vary slightly in composition to achieve the desired curing properties. The lonnations vary circure and self-cure formulations will be supplied in both Smartmix syringes and Automix cartridges. "Luxatemp Ultra" and "Luxatemp Star" are different trade names for the same material

#### Predicate Device:

Luxatemp Ultra/Star is substantially equivalent to the currently marketed DMG USA Luxatemp olira otar is oubolandally vqs. cleared in K013674. Luxatemp / Luxatemp Solar and Luxatemp Ultra/Star differ only slightly in material composition, resulting in improved material properties (e.g., compressive and flexural strength) and curing time. A light-cure inducing component has also been added to allow for dual-cure.

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DMG USA. Inc. K101710/Amendment 1

August 16, 2010 Luxatemp Uitra/Star

### Safety and Performance:

Luxatemp Ultra/Star is a temporary crown and bridge material that complies with the requirements described in ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry. Performance testing has been performed to demonstrate that Luxatemp Ultra/Star is equivalent to or better than the predicate devices in terms of several material properties including compressive strength, flexural strength, tensile strength, hardness, water sorption, working time and curing time. Where applicable, the test methods and requirements described in ISO 4049:2000 Dentistry - Polymer-based filling, restorative and luting materials.

### Conclusion:

Based on the indications for use, technological characteristics, and comparison to the predicate device, the Luxatemp Ultra/Star has been shown to be safe and effective for its intended use.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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

SEP 2 8 2010

Re: K101710

Trade/Device Name: Luxatemp Ultra/Star Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: August 16, 2010 Received: August 25, 2010

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 ffor 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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- 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 ogencies. You must comply with all the Act's requirements, including, but not limited to: agenstration . and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device represent (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 53) -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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, (2) GED D 4 807 00) - 1 807 00 - 1 807 00 - 1 2 - 1 - 1 - 0 - 1 - 0 - 1 - 0 - 0 - 0 - 0 - 0 - 0 - 0 - 0 - 0 - 0 - 0 - 0 - 0 - 0 - 0 - 0 - 0 - 0 - 0 - 0 - 0 - 0 - 0 - 0 - 0 - (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

1h. for

Anthony D. Watson, B.S., M.S., M.B.A. 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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KI6/710

DMG USA, Inc. Abbreviated 510(k) Premarket Notification 20 Mav 2010 Luxatemp Ultra/Star

Page

510(k) Number (if known): Klol 710

Device Name: Luxatemp Ultra/Star

2 8 2010 SEP

### Product Indications for Use:

Luxatemp Ultra/Star is a self-curing or dual-curing composite for the fabrication of temporary crowns and bridges, inlays, onlays and veneers.

Luxatemp Ultra/Star is intended for the fabrication of:

- temporary crowns
- bridges
- inlays
- onlays ●
- long-term temporaries
- temporary veneers .

Luxatemp Ultra/Star is also indicated for incorporation of most mechanically anchored attachment components into the acrylic base of a denture, an overdenture or partial denture.

OR

Prescription Use X (Per 21 CFR 801 Subpart D) Over-the -Counter Use _ (Per 21 CFR 801 Subpart C)

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|----------------------------------------------------------------------------------------------------------|---------|
| (Division Sign-Off)<br>Division of Anesthesiology, General Hospital<br>Infection Control, Dental Devices | |
| 510(k) Number: | K101710 |