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 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.

AI/ML Overview

This 510(k) submission for LuxaBite, a dental bite registration material, indicates that no performance or safety data was included in the premarket notification. Therefore, this document does not contain information on acceptance criteria or a study proving the device meets those criteria.

The submission explicitly states under the "Safety and Performance" section: "Substantial equivalence for this device was based solely on design and technical specifications; no performance or safety data was included in this premarket notification."

Consequently, I cannot provide the requested information regarding acceptance criteria, reported device performance, study details (sample sizes, provenance, expert qualifications, adjudication methods), MRMC studies, standalone performance, or ground truth establishment based on the provided text. The submission relies entirely on a claim of substantial equivalence to predicate devices based on design and technical specifications.

Summary

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OCT 1 7 2001

510(k) Summary

Trade Name:	LuxaBite
Sponsor:	DMG USA, Inc.414 South State StreetDover, DE 19901Registration # not yet assignedOwner/Operator No. 9005969
Device GenericName:	Dental bite registration material
Classification:	According to Section 513 of the Federal Food, Drug, andCosmetic 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:

Indications for Use:

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.

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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.

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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 (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 notification (21 OF ICP at 2001 the Division of Small Manufacturers, International and the Net ind of occurities to 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

Timo 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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September 17, 2001 LuxaBite

000008

1 of of 1 Page _

510(k) Number (if known): KQ13236

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

(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

Regulation Number and Section

§ 872.3660 Impression material.

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