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 Description

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.

AI/ML Overview

This document is a 510(k) summary for a dental provisional material, not an AI/ML device study. Therefore, the requested information regarding acceptance criteria, study details, and AI/ML specific metrics is not applicable and cannot be extracted from this text.

The closest relevant section is:

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."

This statement indicates that no new performance testing was conducted or required for this 510(k) submission because the device was considered substantially equivalent to already cleared predicate devices based on its materials, design, and performance characteristics.

Therefore, I cannot provide the requested table or details about a study for acceptance criteria because such a study was not performed or referenced in this document.

Summary

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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.414 South State StreetDover, DE 19901Registration # not yet assigned
Device Generic Name:	Provisional crown and bridge material
Classification:	According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class II (76EBG;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:

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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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	✓	OR	Over-the -Counter Use
(Per 21 CFR 801.109)

	Susan Ruppe (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
FRolk Number	0013474

000008

Regulation Number and Section

§ 872.3770 Temporary crown and bridge resin.

(a)
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.(b)
Classification. Class II.