(103 days)
Not Found
No
The description focuses on the material properties and curing mechanisms of a dental composite, with no mention of AI or ML.
No
The device is described as a composite for fabricating temporary crowns, bridges, inlays, onlays, and veneers, which are restorative rather than therapeutic in nature. The performance studies also focus on material properties.
No
The device is described as a composite material used for fabricating temporary dental restorations, not for identifying diseases or conditions.
No
The device description clearly indicates it is a composite material supplied in syringes and cartridges, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Luxatemp Ultra/Star is for the fabrication of temporary dental restorations (crowns, bridges, inlays, onlays, veneers) and for incorporating attachment components into dentures. This is a dental restorative material, not a diagnostic test.
- Device Description: The description confirms it's a self-curing or dual-curing composite material used for fabrication.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device is a material used in a dental procedure.
N/A
Intended Use / 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.
Product codes
EBG
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
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DMG USA, Inc. K101710/Amendment 1
17
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 Drive | |
| Attleboro, MA 02703 | |
| Owner/Operator No. 9005969 | |
| Device Generic Name: | Temporary crown and bridge material |
| Classification: | According to Section 513 of the Federal Food, Drug, and |
| Cosmetic 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:
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
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.
1
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.
2
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.
3
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
4
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.
OR
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 Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K101710 |