(49 days)
Not Found
No
The summary describes a dental cement and does not mention any AI or ML capabilities.
No
The device is a dental cement, used for bonding dental devices and repairing dental structures, not for treating or curing a disease or condition. It acts as an adhesive.
No
The device is a dental cement used for various applications like luting and repair, indicating it is a therapeutic or restorative device, not one designed for diagnosis.
No
The device description clearly states it is a "self curing dental cement," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for dental procedures like luting, repair, and cementation of dental devices. This is a direct application within the patient's mouth or on dental prosthetics, not for testing samples taken from the body.
- Device Description: The description confirms it's a dental cement used for physical applications in dentistry.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This dental cement does not fit that definition.
N/A
Intended Use / Indications for Use
For use as a dental cement in various applications, including luting, repair of fractured porcelains or crown and bridge resins, cementaiton of adhesive bridge prostheses and CR core posts.
Product codes
EMA
Device Description
The product is a self curing dental cement for use in the cementation of dental devices, luting, repair of fractured porcelains or crown and bridge resins, cementation of adhesive bridges and CR core posts.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For use only by dental practitioners; it is not intended for OTC use.
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
Not Found
Key Metrics
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
JUL -7 1999
EXHIBIT D
510(k) Summary
Submitted by: Daniel J. Manelli Farkas & Manelli, P.L.L.C. 2000 M Street, NW (Suite 700) Washington, DC 20036
On behalf of Tokuyama America, Inc. 510(k) Submission: Bistite II SC May 6, 1999
The product is a self curing dental cement for use in the cementation of dental devices, luting, repair of fractured porcelains or crown and bridge resins, cementation of adhesive bridges and CR core posts.
This product is for use only by dental practitioners; it is not intended for OTC use. It contains materials that pose no health hazard when used according to directions and has received the approval of the Japanese Government. It is substantially equivalent to various marketed dental cement products, including the following:
| Panavia 21 (Kurarey) | K933030 |
|---|---|
| Panavia Ex (Kurarey) | K855211 |
| C&B Metabond (Parkell) | K960464 |
The Use of the product is contra-indicated for patients who are hypersensitive to methacrylate monomers. It should not be allowed to come into contact with skin, eyes or clothing. Should contact with the eyes occur, the eyes should be thoroughly flushed with water followed by immediate contact to a physician.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three curved lines representing its wings. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 7 1999
Tokuyama America, Incorporated c/o Daniel J. Manelli Farkas & Manelli, P.L.L.C. 2000 M Street, N.W. 7th Floor Washington, DC 20036-3307
Re : K991711 Trade Name: Bistite II SC Regulatory Class: II Product Code: EMA May 17, 1999 Dated: May 19, 1999 Received:
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 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 requlations 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) requlation (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 Reqister.
2
Page 2 - Mr. Manelli
this response to your premarket notification Please note: ricable note. Confor 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.
This letter will allow you to begin marketing your device as fire roceer wire as 0 (k) premarket notification. The FDA deberroom in four in four alence of your device to a legally marketed predicate device results in a classification for your marice 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 compriation 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
Directo Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):_|