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

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental material, Luxatemp Ultra/Star, intended for temporary dental restorations. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with human readers or AI algorithms as would be expected for a diagnostic AI device.

Therefore, many of the requested points are not applicable to this specific submission. However, I will extract the relevant information and explicitly state when a point is not applicable.

Acceptance Criteria and Device Performance

1. A table of acceptance criteria and the reported device performance

The document states that Luxatemp Ultra/Star aims to be "equivalent to or better than the predicate devices." While specific numerical acceptance criteria (e.g., minimum compressive strength) are not provided in detail within the summary, the document indicates compliance with ISO and a comparison to the predicate.

Acceptance Criteria Category	Predicate Device Standard / Regulation	Reported Device Performance (Luxatemp Ultra/Star)
Biocompatibility	ISO 7405:2008 Dentistry - Evaluation of biocompatibility	Complies with requirements of ISO 7405:2008
Material Properties	ISO 4049:2000 Dentistry - Polymer-based filling, restorative, and luting materials (where applicable)	Equivalent to or better than the predicate device in terms of compressive strength, flexural strength, tensile strength, hardness, water sorption, working time, and curing time.
Substantial Equivalence	Comparison to legally marketed predicate (DMG USA Luxatemp cleared in K013674)	"Substantially equivalent" to predicate based on indications for use, technological characteristics, and material properties.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This submission is for a dental material and does not involve a "test set" of patient data or images in the context of an AI/diagnostic device. The testing involved material property measurements. The document does not specify the sample size for these material tests or their geographic origin, but typical premarket submissions for materials involve laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This submission is for a dental material. The "ground truth" for material properties is established by standardized laboratory testing methods, not by expert consensus or interpretations of patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. This submission is for a dental material. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical studies involving interpretation (e.g., by human readers), which is not relevant here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This submission is for a dental material and does not involve AI or human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This submission is for a dental material and does not involve an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context refers to the established physical and chemical properties of dental materials as determined by standardized laboratory tests. These tests are designed to measure properties like compressive strength, flexural strength, tensile strength, hardness, water sorption, working time, and curing time according to recognized international standards (ISO 4049:2000 and ISO 7405:2008). The predicate device's established performance served as the benchmark for demonstrating equivalence or superiority.

8. The sample size for the training set

Not Applicable. This submission is for a dental material and does not involve machine learning or a "training set" of data.

9. How the ground truth for the training set was established

Not Applicable. This submission is for a dental material and does not involve machine learning or a "training set." The performance of the material is established through direct, standardized laboratory testing.

Summary

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DMG USA, Inc. K101710/Amendment 1

August 16, 2010 Luxatemp Ultra/Star

510(k) Summary
Trade Name:	Luxatemp Ultra/Star
Date Prepared:	August 16, 2010
Sponsor:	DMG USA, Inc.23 Frank Mossberg DriveAttleboro, MA 02703
	Owner/Operator No. 9005969
Device Generic Name:	Temporary crown and bridge material
Classification:	According to Section 513 of the Federal Food, Drug, andCosmetic 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:

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 (800) 638-2041 or (301) 796-7100 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.

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)Division of Anesthesiology, General HospitalInfection Control, Dental Devices
510(k) Number:	K101710

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.