(91 days)
Not Found
Not Found
No
The summary describes a dental luting agent, a chemical substance used for temporary cementation, with no mention of software, image processing, or AI/ML terms.
No
The device is described as a "dental luting agent for the temporary cementation of crowns and bridges," which is used in dentistry to hold things in place, not to treat a disease or condition.
No
Explanation: The device, TempoCem N/E, is a dental luting agent for temporary cementation, which is a treatment function, not a diagnostic one.
No
The device is described as a "dental luting agent," which is a physical material used for temporary cementation. This indicates it is a hardware/material-based device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "a dental luting agent for the temporary cementation of crowns and bridges." This describes a material used directly on a patient's teeth for a physical purpose (holding a restoration in place).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
The function of TempoCem N/E is a physical application within the mouth, not a diagnostic test performed on a biological sample.
N/A
Intended Use / Indications for Use
TempoCem N/E is a dental luting agent for the temporary cementation of crowns and bridges.
Product codes
EMA
Device Description
Not Found
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
dentist, or other practitioner licensed by the order of a dencise, or hich he or she practices to use or order the use of this device.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top and left side. Inside the circle is a stylized symbol resembling an abstract human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 3 1997
Mr. D. Tim Wolf Regulatory Affairs Manager Foremost Dental Mfg, Incorporated worse 242 - South Dean Street Englewood, New Jersey 07631
K970774 Re : TempoCem N/E (Multiple) Trade Name: Regulatory Class: II Product Code: EMA Dated: April 25, 1997 Received: April 29, 1997
Dear Mr. Wolf:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. पुर substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your
1
Page 2 - Mr. Wolf
premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as a too described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 pr (301) 443-6597 or at its internet address "http://www.fda.goy/cdrh/dsmamain.html".
Sincerely yours,
Timo iv A. Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page_ ol
510(k) Number (il known):
Ocvice Name: (Multiple)
Indications I-or Usc:
TempoCem N/E is a dental luting agent for the temporary rempocem W/D 15 a dental frowns and bridges.
Federal law restricts this device to sale by, or on the order of a dentist, or other practitioner licensed by the order of a dencise, or hich he or she practices to use or order the use of this device.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED!
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Turner
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
intestipuon lise 1900 21 000 809
4 ) : :
Over-the-Counter Use No
Collenai Formal 1-2-951
SK-49