(184 days)
Vintage Press, Vintage LF and Vintage LF Stain are dental porcelain system used for fabricating restorations (all ceramic crown and/or metal ceramic crown), build up on a ceramic substructure and/or on a metal substructure .
Vintage Press, Vintage LF, Vintage LF Stain Dental Ceramic
This document is a 510(k) clearance letter from the FDA for a dental ceramic product. It is a regulatory approval document and does not contain information about acceptance criteria or performance studies for an AI/ML powered device. Therefore, I cannot provide the requested information.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 5 2004
Mr. Robert Noble President Shofu Dental Corporation 1225 Stone Drive San Marcos, California 92069-4059
Re: K032416
Trade/Device Name: Vintage Press, Vintage LF, and Vintage LF Stain Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Codc: EIH Dated: January 22, 2004 Received: January 26, 2004
Dear Mr. Noble:
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. Robert Noble
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 (OS) 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,
Cls
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K032416
Vintage Press, Vintage LF, Vintage LF Stain Dental Ceramic
Indication for Use
Vintage Press, Vintage LF and Vintage LF Stain are dental porcelain system used for fabricating restorations (all ceramic crown and/or metal ceramic crown), build up on a ceramic substructure and/or on a metal substructure .
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use $\checkmark$ or
Over -The-Counter Use
Susan Rumo
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: CO32416
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.