(47 days)
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No
The provided text describes a temporary dental cement and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
This device is a temporary dental cement used for interim cementation of restorations like inlays, crowns, and bridges, which is a supportive material rather than a device intended to treat or cure a disease or condition.
No
Explanation: The device, UltraTemp, is described as a "non-eugenol temporary cement indicated for interim cementation of inlays, crowns and bridges." This indicates it is used for restorative or procedural purposes, not for diagnosing a disease or condition.
No
The 510(k) summary describes a temporary cement, which is a physical material, not software.
Based on the provided information, UltraTemp is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes UltraTemp as a temporary cement for dental restorations (inlays, crowns, bridges). This is a material used in the mouth for a physical purpose (cementation).
- Lack of Diagnostic Purpose: There is no mention of UltraTemp being used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
IVDs are typically used to test samples like blood, urine, tissue, etc., to gain information about a patient's health status. UltraTemp's function is purely mechanical and temporary within the oral cavity.
N/A
Intended Use / Indications for Use
UltraTemp is a non-eugenol temporary cement indicated for interim cementation of inlays, orowns and bridges. It is polycarboxylate based and does not negatively affect resin bonding. Being water soluhle until set, it cleans up easily.
Product codes
EMA
Device Description
UltraTemp is a non-eugenol temporary cement. It is polycarboxylate based and is water soluble until set.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an emblem featuring a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 2000
Mr. Scott E. Moore Regulatory Affairs Manager Ultradent Products, Incorporated 505 West 10200 South South Joardan, Utah 84095
Re: K994261 Trade Name: UltraTemp Temporary Polycarboxylate Cement Regulatory Class: II Product Code: EMA Dated: December 8, 1999 Received: December 17, 1999
Dear Mr. Manelli:
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 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 (Premarket Approval), it may be subject to such additional controls. Exisping major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ನ್ 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 regulation 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 premarket notification submission does not affect any
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Page 2 - Mr. Manelli
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 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 regulation (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 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timo Ulatowski Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page_1_of_1
K994261 510(k) Number (if known): Unknown
Device Name: _____________________________________________________________________________________________________
Indications For Use:
UltraTemp is a non-eugenol temporary cement indicated for interim cementation of inlays, orowns and bridges. It is polycarboxylate based and does not negatively affect resin bonding. Being water soluhle until set, it cleans up easily.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
V Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Susan Runyon
(Optional Format 1-2-90
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital I !- 1 Q(k) Number