(64 days)
None
Not Found
No
The summary describes a dental alloy for restorations and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is described as an alloy for dental restorations like crowns and bridges, which are used to restore the function and appearance of teeth, not to treat a disease or condition in a therapeutic manner.
No
The device, an alloy, is intended for dental restorations (crowns, bridges, posts), which are therapeutic/restorative purposes, not for diagnosing medical conditions.
No
The intended use describes a physical dental alloy used for crowns and bridges, which is a hardware component, 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 as being used for dental restorations (crowns, posts, bridges, PFM crowns). These are devices used in vivo (within the body) for structural purposes, not for testing samples in vitro (outside the body) to diagnose conditions.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, the Bio Universal PKF alloy, as described, falls under the category of a dental prosthetic material, not an IVD.
N/A
Intended Use / Indications for Use
Bio Universal PKF alloy intended to be used for crowns, posts, short and long span bridges and PFM crowns.
Product codes
EJT
Device Description
Not Found
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
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.
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 stylized eagle or bird symbol, with three curved lines representing the bird's head and wings. The bird is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 2:0850
APR 1 5 2003
Mr. Anderjeet Gulati Quality Assurance Manager Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228
Re: K030435
Trade/Device Name: BioUniversal PKF Regulation Number: 21 CFR 872.3060 Regulation Name: Gold Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Codes: EJT Dated: February 03, 2003 Received: February 10, 2003
Dear Mr. Gulati:
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.
1
Page 2 - Mr. Anderjeet Gulati
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,
Susan Rupper
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
2
| 510(k) Number (if known): K030435 | Comments of Children Comments of Children Comments of Children Comments of Children | Comments of the control of the control of the consisted on the consisted on the control of the contribution of the contribution of the contribution of the contribution of the
Comments of the program and the first of the first and the first and the first and the may be |
| ---------------------------------------- | ------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Device Name:
BioUniversal PKF
Indications For Use:
Bio Universal PKF alloy intended to be used for crowns, posts, short and long span bridges and PFM crowns.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109) OR
Over-The-Counter Use_
Rein Muly for MSR
(Optional Format 1-2-96)
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control. Dental Devices
510(k) Number. K030435