(47 days)
No
The document describes a temporary dental resin and its intended use, device description, and performance studies. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The focus is on the material properties and equivalence to predicate devices.
No
The device is a temporary crown and bridge resin used to fabricate temporary dental prostheses, not to treat a disease or condition. It is classified as an FDA Class II dental device, which aligns with its restorative, non-therapeutic function.
No
The device, TempXN28, is a temporary crown and bridge resin used for fabricating temporary dental prostheses. Its function is to create a physical restoration, not to diagnose a condition or disease.
No
The device description clearly states it is a "temporary crown and bridge resin," which is a physical material, not software. It also mentions a "Garant™ mixing and dispensing system," which is hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fabrication of temporary dental restorations (crowns, bridges, etc.). This is a direct application to the patient's anatomy, not for testing samples taken from the body.
- Device Description: The description clearly states it's a "temporary crown and bridge resin intended to make a temporary prosthesis." This aligns with a dental material used for fabrication.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information.
The device is classified as a Class II dental device (21 C.F.R § 872.3770), which is consistent with a material used for dental prosthetics, not an IVD.
N/A
Intended Use / Indications for Use
"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."
Product codes
EBG
Device Description
"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."
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)
"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."
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
:
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 Crown |
| and Bridge Material |
Predicate Device
| Protemp™ 3 Garant™ by 3M ESPE | K033022 |
|---|---|
| Luxatemp Fluorescence by DMG USA, Inc. | K013674 |
| Sinfony by 3M ESPE | K992645 |
:
·
1
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.
2
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.
3
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
4
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
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