(48 days)
Not Found
No
The 510(k) summary describes a dental cement for post cementation and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is a cement used for permanent cementation of endodontic posts, which is a restorative rather than therapeutic function.
No
The device, ParaCem cement, is described as being for the "permanent cementation of endodontic posts into root canals." This is a treatment or restorative function, not a diagnostic one. It does not identify or detect a disease or condition.
No
The device is a cement, which is a physical material, not software. The 510(k) summary describes a product for permanent cementation, indicating a tangible substance.
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 endodontic posts into root canals. This is a procedure performed directly on a patient's body (in vivo) to restore a tooth.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
The ParaCem cement is a material used in a dental procedure, not a test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
ParaCem cement is for the discretionary use by dentists for the permanent cementation of endodontic posts into root canals after endodontic therapy has been completed.
Product codes
EMA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canals
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentists
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)
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 a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The seal appears to be a logo or emblem for the U.S. Department of Health and Human Services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 1 1999
Mr. H.J. Vogelstein Official Correspondent Coltene Whaledent Incorporated 750 Corporate Drive Mahwah, New Jersey 07430
Re : K993710 Trade Name: Modification of Parapost Cement Regulatory Class: II Product Code: EMA Dated : November 1, 1999 Received: November 3, 1999
Dear Mr. Vogelstein:
Wc 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMF, regulation (21 CFR Part 820) and that, through periodic GMF inspections, the Food and Drug Administration (FDA) will verily such assumptions. Failure to comply with the GMP . Gulation 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
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Mr. Vogelstein Page 2
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 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 or (301) 443-6597 or at its internet address "http://www.fdag.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowsk Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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Enclosure
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Coltène/Whaledent Inc.
Amended Submission to K945366 Para Post Cement Indications for Use
ParaCem cement is for the discretionary use by dentists for the permanent cementation
of endodontic posts into root canals after endodontic therapy has been completed.
Prescription Use
(Per 21 CFR 801.109)
Susan Runyon
(Division Sign-Off) Division of Dental, Infection Con and General Hospital D 510(k) Number
529c
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