(85 days)
Used for bases, linings and to cement crowns and bridges.
It decreases post-operative sensitivity. Bonds to tooth structure.
Glass Ionomer cement called Desens-Ionomer
The provided document is a 510(k) clearance letter from the FDA for a dental cement called "Desens-Ionomer." This type of document does not contain the information requested in your prompt.
Specifically, a 510(k) clearance determines if a new medical device is "substantially equivalent" to an existing legally marketed device (predicate device). It does not typically require the extensive clinical study data, acceptance criteria, or performance metrics that would be found in a Premarket Approval (PMA) application or a detailed clinical study report for software, especially AI-driven medical devices.
Therefore, I cannot extract the following information from the provided text:
- Table of acceptance criteria and reported device performance: This document doesn't define specific performance metrics or acceptance criteria for the "Desens-Ionomer" beyond its stated indications for use (bases, linings, cementing crowns/bridges, decreasing post-operative sensitivity, bonding to tooth structure).
- Sample size used for the test set and data provenance: No clinical study details are provided.
- Number of experts used to establish ground truth and their qualifications: Not applicable to this type of regulatory document.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned and unlikely for a dental cement 510(k).
- Standalone (algorithm only) performance: Not applicable as this is a physical dental cement.
- Type of ground truth used: No mention of ground truth as a clinical study is not detailed.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The letter confirms that the FDA reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, overlaid with three curved lines that resemble an abstract bird in flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 9 2003
Dr. Milton Hodosh Milton Hodosh DMD, Incorporated 243 Elmwood Avenue Providence, Rhode Island 02907
Re: K032175 Trade/Device Name: Desens-Ionomer Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: October 03, 2003 Received: October 06, 2003
Dear Dr. Hodosh:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Dr. Milton Hodosh
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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). please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu S. Lin, PhD
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Page of
510(k) Number (if known): K032175
Device Name: Glass Ionomer cement called Desens-Ionomer
Indications for Use:
Used for bases, linings and to cement crowns and bridges.
It decreases post-operative sensitivity. Bonds to tooth structure.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use _____________________________________________________________________________________________________________________________________________________________ CFR 801.109)
OR
Over-the-Counter Use ______(Per 21
(Optional Format 1-2-96)
Susan Runne
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K032175
§ 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.