(57 days)
Not Found
No Reference Device(s) K/DEN number are listed in the text.
No
The provided text describes a dental restorative material and its intended uses. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The provided text describes a material suitable for dental restorations and fillings, which are restorative procedures, not therapeutic.
No
Explanation: The device is described for use in restorations and fillings, which are treatment procedures, not diagnostic ones.
No
The provided text describes a dental restorative material, which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device's application in dental restorations and fillings. This is a direct treatment or repair of a physical condition within the body.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease or condition, or to examine specimens taken from the body (which is the core function of an IVD).
- Anatomical Site: While not explicitly stated, the intended use points to application within the oral cavity, which is a part of the body, not a specimen.
IVDs are devices used to examine specimens (like blood, urine, tissue) taken from the body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is clearly therapeutic and restorative, not diagnostic.
N/A
Intended Use / Indications for Use
Suitable for use in non-load bearing Class I and II restorations, Class V restorations, paediatric and geriatric applications, core build-ups, root surface restorations and semipermanent fillings.
Also suitable for use as a base material for Class I and II cavities using the sandwich technique with composite restorations.
Product codes
EMA
Device Description
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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
paediatric and geriatric
Intended User / Care Setting
Not Found
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)
Not Found
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 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 an eagle with three lines extending from its head, representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 7 2003
Ms. Samantha J. Cheetham Official Correspondent Southern Dental Industries, Incorporated 729 North Route 83, Suite 315 Bensenville, Illinois 60106
Re: K030516
Trade/Device Name: Riva Self Cure Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Codes: EMA Dated: February 14, 2003 Received: February 19, 2003
Dear Ms. Cheetham:
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 - Ms. Samantha J. Cheetham
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 vour responsibilities under the Act mav 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,
Susan Runge
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known):
Device Name:
Indications For Use:
KO 30 516
Riva Self-cure
Suitable for use in non-load bearing Class I and II restorations, Class V restorations, paediatric and geriatric applications, core build-ups, root surface restorations and semipermanent fillings.
Also suitable for use as a base material for Class I and II cavities using the sandwich technique with composite restorations.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suren Ruager
v. General Hospital. sthesir ol, Dental Device
Prescription Use: 510(k) Numbe (Per 21 CFR 801.109)
Over-The-Counter Use: ________________________________________________________________________________________________________________________________________________________