K Number
K013674
Device Name
LUXATEMP/LUXATEMP SOLAR/INSTATEMP
Manufacturer
Date Cleared
2002-01-24

(78 days)

Product Code
Regulation Number
872.3770
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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.
More Information

No
The device description and intended use are for dental composite materials, and there is no mention of AI or ML in the provided text.

No
The device is described as a composite material for temporary dental restorations and for incorporating attachment components into dentures, which are structural and restorative functions, not therapeutic.

No

The device is described as a self-cure/dual-cure provisional crown and bridge composite material used for temporary dental restorations and incorporation of attachment components into dentures, which are restorative purposes, not diagnostic.

No

The device description clearly states it is a "bis-acrylic composite material," which is a physical substance, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use/Indications for Use: The intended use is for creating temporary dental restorations (crowns, bridges, inlays, onlays) and incorporating attachment components into dentures. This is a direct application within the patient's mouth or on dental prosthetics, not for testing samples taken from the body.
  • Device Description: The description details the material composition and its use in creating these dental devices. There is no mention of analyzing biological samples.
  • Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Providing diagnostic information about a patient's health
    • Using reagents or assays for testing

The device is a dental material used for restorative and prosthetic purposes, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

EBG

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K924830, K944981

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K011211

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

0

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 Street
Dover, DE 19901
Registration # not yet assigned
Device Generic Name:Provisional crown and bridge material
Classification:According to Section 513 of the Federal Food, Drug, and
Cosmetic 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:

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.

1

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.

2

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

3

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 UseOROver-the -Counter Use
(Per 21 CFR 801.109)
Susan Ruppe (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
FRolk Number0013474

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