BIO UNIVERSAL by IVOCLAR VIVADENT, INC.

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental alloy device (BioUniversal). This type of document does not contain information about acceptance criteria for a medical device's performance, nor does it describe a study proving the device meets such criteria in the context of AI or advanced analytical performance.

The document is a regulatory approval notice, confirming that the device is substantially equivalent to a legally marketed predicate device and can therefore be marketed. It discusses regulatory classifications, general controls, and compliance requirements, but does not delve into specific performance metrics or studies of the type you've outlined (e.g., diagnostic accuracy, expert consensus, training sets for AI).

Therefore, I cannot extract the requested information from the provided text.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Anderjeet Gulati Quality Assurance Manager Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst. New York 14228

APR 1 5 2003

Re: K030436

Trade/Device Name: BioUniversal 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: January 30, 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 vours.

Susan Prooner

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}------------------------------------------------

Page 1 of 1

510(k) Number (if known):	K030436
---------------------------	---------

Bio Universal Device Name: ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Indications For Use:

Bio Universal 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	OR	Over-The-Counter Use
(Per 21 CFR 801.109)

	Kei Muly
	for MSR
(Division Sign-Off)	(Optional Format 1-2-96)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number	K030436
---------------	---------

Regulation Number and Section

§ 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.