(61 days)
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Not Found
No
The summary describes a traditional dental cement and contains no mention of AI, ML, image processing, or performance studies typically associated with AI/ML devices.
No.
The device is a dental cement for permanent cementation of crowns and bridges, which is used for restorative purposes rather than for preventing, diagnosing, treating, or curing a disease.
No
The device, ZinFos Zinc Phosphate Cement, is explicitly described for "permanent cementation of Crowns and bridges," indicating a therapeutic or restorative function, not a diagnostic one.
No
The device description clearly identifies it as "ZinFos Zinc Phosphate Cement," which is a physical material used for dental procedures, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the permanent cementation of crowns and bridges on teeth. This is a dental procedure performed directly on a patient's body.
- Device Description: The device is a Zinc Phosphate Cement, which is a material used in dental restorations.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples for diagnostic purposes. This device is used inside the body for a restorative dental procedure.
N/A
Intended Use / Indications for Use
For permanent cementation of Crowns and bridges on non-vital teeth and on vital teeth where the use of Conventional Zinc Phosphate Cements is judged appropriate.
Product codes
EMA
Device Description
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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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with its wings spread, composed of three curved lines that create the impression of a human profile within the negative space. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 9 1998
Dr. Jan A. Orlowski Scientific Pharmaceuticals, Incorporated 3221 Producer Way 91768 Pomona, California
K982913 Re : ZinFos Zinc Phosphate Cement Trade Name: Regulatory Class: II EMA Product Code: Dated: August 14, 1998 Received: August 19, 1998
Dear Dr. Orlowski
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. A 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 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.
1
Page 2 - Dr. Orlowski
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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 qeneral 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.fdag.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowski Director 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
K982913 510(k) NUMBER (IF KNOWN):
ZinFos ZINC PHOSPHATE CEMENT DEVICE NAME:
INDICATIONS FOR USE:
For permanent cementation of Crowns and bridges on non-vital teeth and on vital teeth where the use of Conventional Zinc Phosphate Cements is judged appropriate.
(PLEASE DO NO" WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
*None of the above: FOR PROFESSIONAI USE ONIY
Susan Rumm
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number