LUXATEMP/LUXATEMP SOLAR/INSTATEMP

K013674 · Dmg USA, Inc. · EBG · Jan 24, 2002 · Dental

Device Facts

• Record ID: K013674
• Device Name: LUXATEMP/LUXATEMP SOLAR/INSTATEMP
• Applicant: Dmg USA, Inc.
• Product Code: EBG · Dental
• Decision Date: Jan 24, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2

Intended Use

Luxatemp / InstaTemp are self-cure provisional crown and bridge composites for use in temporary crowns and bridges, long-term temporaries, inlays and onlays. Luxatemp Solar is a dual-cure provisional crown and bridge composite for use in temporary crowns and bridges, long-term temporaries, inlays and onlays. Luxatemp / Luxatemp Solar / InstaTemp are 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, Luxatemp Solar, and InstaTemp are bis-acrylic composite materials used by dental professionals for fabricating temporary dental restorations (crowns, bridges, inlays, onlays) and for securing attachment components into prosthetic bases. Luxatemp and InstaTemp are self-curing, while Luxatemp Solar is dual-curing. The material is applied by the clinician to the prepared site to form a temporary structure. By providing a stable, temporary restoration, the device protects the prepared tooth structure and maintains space/occlusion while a permanent restoration is fabricated. The device is used in a clinical dental setting.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Bis-acrylic composite material. Luxatemp/InstaTemp: self-cure. Luxatemp Solar: dual-cure. Formulated for provisional crown/bridge fabrication and attachment pickup.

Indications for Use

Indicated for patients requiring temporary crowns, bridges, inlays, onlays, or long-term temporaries, and for the incorporation of mechanically anchored attachment components into denture, overdenture, or partial denture bases.

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 (K924830)
• Iso-Temp (K944981)
• DMG USA, Inc. Flowable Composite (K011211)

Submission Summary (Full Text)

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K013674 Luxatemp / Luxatemp Solar / InstaTemp
October 17, 2001

# JAN 2 4 2002

# 510(k) Summary

| Trade Name: | Luxatemp / Luxatemp Solar / InstaTemp |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | DMG USA, Inc.<br>414 South State Street<br>Dover, DE 19901<br>Registration # not yet assigned |
| Device Generic Name: | Provisional crown and bridge material |
| Classification: | According to Section 513 of the Federal Food, Drug, and<br>Cosmetic Act, the device classification is Class II (76EBG;<br>21 CFR 872.3770). |

# Predicate Devices:

In terms of chemical composition and physical properties, the proposed Luxatemp / InstaTemp material for attachment pickup usage is identical to the Luxatemp material cleared for marketing in K924830 and Luxatemp Solar material for attachment pickup usage is identical to the Iso-Temp material cleared for marketing in K944981 . The inclusion of attachment pickup techniques in the product labeling is similar to that found in the labeling for the DMG USA, Inc. Flowable Composite material found substantially equivalent by FDA in K011211.

# Product Description & Indications:

Luxatemp / InstaTemp are self-cure bis-acrylic composite materials for use in the preparation of temporary crowns and bridges, inlays and onlays. Luxatemp Solar is a dual-cure bis-acrylic composite material for use in the preparation of temporary crowns and bridges, inlays and onlays Luxatemp / Luxatemp Solar / InstaTemp are also indicated for incorporation of most mechanically anchored attachment components into the acrylic base of a denture, an overdenture, or partial denture.

## Safety and Performance:

Substantial equivalence for this device was based on similarities in materials, design and performance characteristics. No safety or performance testing was required to establish substantial equivalence for Luxatemp / Luxatemp Solar / InstaTemp materials.

## Conclusion:

Based on the indications for use, technological characteristics, and comparison to predicate devices, the DMG USA Luxatemp / Luxatemp Solar / InstaTemp materials have been shown to be safe and effective for their intended use.

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Image /page/1/Picture/12 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 an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 4 2002

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

Re: K013674

Trade/Device Name: Luxatemp/ Luxatemp Solar/ InstaTemp Regulation Number: 872.3770 Regulation Name: Provisional Crown and Bridge Material Regulatory Class: II Product Code: EBG Dated: October 30, 2001 Received: November 7, 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 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.

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.

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## Page 2 - Ms. Papineau

You must comply with all the Act's requirements, including, but not limited to: registration r od interests (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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). Other general information on your 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 Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _Luxatemp / Luxatemp Solar / InstaTemp

Indications for Use:

Luxatemp / InstaTemp are self-cure provisional crown and bridge composites for use in temporary crowns and bridges, long-term temporaries, inlays and onlays.

Luxatemp Solar is a dual-cure provisional crown and bridge composite for use in temporary crowns and bridges, long-term temporaries, inlays and onlays.

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div style="display:flex; align-items:center;"> ✓ </div> | OR | Over-the -Counter Use |
|----------------------|--------------------------------------------------------------------------------------|----|-----------------------|
| (Per 21 CFR 801.109) | | | |

| | <div><i>Susan Ruppe</i></div> <div>(Division Sign-Off)</div> <div>Division of Dental, Infection Control,</div> <div>and General Hospital Devices</div> |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| FRolk Number | 0013474 |

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