(47 days)
Fabrication of temporary crowns, bridges, inlays, onlays and veneers.
Fabrication of long-lasting temporary restorations. Lining material for prefabricated temporary crowns made of composite and metal.
TempXN28 is a temporary crown and bridge resin intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated. Temporary crown and bridge resin is designated at 21 C.F.R § 872.3770 as a Class II device.
Like Protemp™ 3 Garant™, TempXN28 is available in the proven Garant™ mixing and dispensing system.
The provided text is a 510(k) Summary for a dental material (TempXN28) and not a study describing the performance of an AI/ML powered device. As such, the requested information pertaining to AI/ML device acceptance criteria, study design, and performance metrics (e.g., sample size for test set, ground truth establishment, MRMC studies, standalone performance) is not available in the given document.
The document discusses the safety and effectiveness of the dental material TempXN28 by demonstrating its substantial equivalence to predicate devices (Protemp™ 3 Garant™, Luxatemp Fluorescence, and Sinfony).
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as quantifiable metrics for a software/AI device. For this dental material, acceptance criteria would typically involve biocompatibility, mechanical properties (e.g., flexural strength, wear resistance), polishability, color stability, and ease of use, all within acceptable ranges or comparable to predicate devices.
- Reported Device Performance: The document generally states: "To provide evidence for safety biocompatibility testing was carried out. The results show that TempXN28 is a safe device. The comparison for chemistry, performance data and indications for use shows that TempXN28 is substantially equivalent to the predicate devices."
- No specific performance values (e.g., strength in MPa, fill rate, etc.) are provided in this summary.
| Acceptance Criteria (Implied for Dental Material Equivalence) | Reported Device Performance (Implicit from Summary) |
|---|---|
| Biocompatibility (Safety) | Biocompatibility testing carried out, results show TempXN28 is a safe device. |
| Performance Data (e.g., mechanical, chemical properties) | Comparison for chemistry and performance data shows substantial equivalence to predicates. |
| Indications for Use | Substantially equivalent to predicate devices for stated indications. |
The following questions cannot be answered from the provided text as they relate to AI/ML device evaluation, which is not the subject of this 510(k) summary:
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
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:
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
.
JAN - 9 2008
Submitter
| Company: | 3M ESPE AG |
|---|---|
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Establishment Registration Number | 9611385 |
| Official Correspondent: | Dr. Andreas Petermann,Manager Regulatory Affairs |
| Phone: | 011-49-8152-700 1395 |
| Fax: | 011-49-8152-700 1869 |
| E-mail: | Andreas.Petermann@mmm.com |
| Date: | November 16, 2007 |
| Name of Device | |
| Proprietary Name: | TempXN28 |
| Classification Name: | Temporary Crown and Bridge Resin |
| Common Name: | Composite based Temporary Crownand Bridge Material |
Predicate Device
| Protemp™ 3 Garant™ by 3M ESPE | K033022 |
|---|---|
| Luxatemp Fluorescence by DMG USA, Inc. | K013674 |
| Sinfony by 3M ESPE | K992645 |
:
·
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Description for the Premarket Notification
TempXN28 is a temporary crown and bridge resin intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated. Temporary crown and bridge resin is designated at 21 C.F.R § 872.3770 as a Class II device.
Like Protemp™ 3 Garant™, TempXN28 is available in the proven Garant™ mixing and dispensing system.
To provide evidence for safety biocompatibility testing was carried out. The results show that TempXN28 is a safe device.
The comparison for chemistry, performance data and indications for use shows that TempXN28 is substantially equivalent to the predicate devices.
In summary, it can be concluded that safety and effectiveness requirements for TempXN28 are completely met.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features the department's name encircling a symbol. The symbol consists of four stylized human figures facing to the right, with their heads connected by a single line, representing the department's focus on health and well-being.
JAN - 9 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Andreas Petermann Manager, Regulatory Affairs 3M ESPE AG Dental Products ESPE Platz Seefeld, Bavaria, GERMANY D-82229
Re: K073296
Trade/Device Name: Temp XN28 Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: November 16, 2007 Received: November 23, 2007
Dear Dr. Petermann:
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.
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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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sutte Y. Michaud MD
Chiu Lin, Ph.D. 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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Indications for Use
510(k) Number (if known):
Device Name:
Indications For Use:
TempXN28
Fabrication of temporary crowns, bridges, inlays, onlays and veneers.
Fabrication of long-lasting temporary restorations. Lining material for prefabricated temporary crowns made of composite and metal.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Susan Rumsey
sion of Anesthesiology, General Hospital,
fection Control, Cumbria, Davids
Page 1 of
§ 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.