(64 days)
Bio Universal PKF alloy intended to be used for crowns, posts, short and long span bridges and PFM crowns.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a dental alloy, BioUniversal PKF. This type of document is a regulatory approval and does not contain information about acceptance criteria or a study proving device performance against such criteria.
The purpose of a 510(k) clearance is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its absolute safety and effectiveness through a new study with acceptance criteria.
Therefore, I cannot provide the requested information from the given text.
To answer your request, I would need a different type of document, such as a clinical study report, a performance validation report, or a detailed product specification document that outlines specific performance criteria and the results of tests conducted to meet them.
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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.
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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
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| 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 theComments of the program and the first of the first and the first and the first and the may be |
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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
§ 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.