(136 days)
This is a chemically activated adhesive that is used in the cementation of inlays, crowns, bridges, facings, and orthodontic brackets. It may also be used as a cavity lining under all restorative materials or following root canal treatment. This adhesive is also used in the cementation of temporary fillings and fillings in deciduous teeth.
Polycarboxylate Cement
This is a 510(k) clearance letter for a Polycarboxylate Cement. 510(k) submissions for devices like this, which are physical materials used in dentistry, typically do not involve the kind of performance studies with acceptance criteria, human experts, and ground truth detailed in your request. Such studies are more common for AI/ML-driven devices or diagnostic tools.
Therefore, I cannot provide the information requested from the provided text for the following reasons:
- Type of Device: Polycarboxylate Cement is a dental restorative material, not an AI-powered diagnostic or predictive device. Its clearance relies on demonstrating substantial equivalence to a legally marketed predicate device, primarily through material properties, biocompatibility, and intended use, rather than clinical performance metrics against a "ground truth" derived from expert interpretation.
- Lack of Clinical Study Details: The provided document is a clearance letter, not a summary of a clinical study or a detailed technical submission. It states that the device is "substantially equivalent" to predicate devices. This equivalence is typically demonstrated through bench testing and comparisons of characteristics, not through studies involving human readers or complex ground truth adjudication.
In summary, there is no information in the provided text to complete the requested table and answer the specific questions about acceptance criteria, clinical study design, expert involvement, or AI/ML performance metrics.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 | 1998
Ms. Debra Olson Official Correspondent Medental International 1246 Clear Creek Road Evergreen, Colorado 80439
Re : K980990 Polycarboxylate Cement Trade Name: Requlatory Class: II Product Code: EMA July 13, 1998 Dated: July 15, 1998 Received:
Dear Ms. Olson:
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, Druq, 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. ਸ 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 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.
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Paqe 2 - Ms. Olson
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,
S. Dutran for
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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MEDENTAL INTERNATIONAL
1246 Clear Creek Road Evergreen, CO 80439 Establishment # 1723973
510(k) Number:
f
Unknown K980990
Device Name:
Polycarboxylate Cement
Indications for Use:
This is a chemically activated adhesive that is used in the cementation of inlays, crowns, bridges, facings, and orthodontic brackets. It may also be used as a cavity lining under all restorative materials or following root canal treatment. This adhesive is also used in the cementation of temporary fillings and fillings in deciduous teeth.
SRunres
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K180442
§ 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.