(68 days)
Non-Precious Dental Casting Alloy . Suitable for use in fabrication of removable dental appliances.
Not Found
The provided document is an FDA 510(k) clearance letter for a dental casting alloy, not a study evaluating an AI-enabled medical device. Therefore, it does not contain information related to acceptance criteria, study methodologies, or AI performance metrics as requested in the prompt.
Specifically, the document establishes the substantial equivalence of the "PD Casta-H" device to legally marketed predicate devices, allowing it to be marketed. This process does not involve the type of performance evaluation, ground truth establishment, or statistical analysis typically associated with AI device studies.
Therefore, I cannot provide the requested information based on the given document.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 7 2003
Ms. Ruth C. Joline Mountain Medico, Incorporated 600 North Mountain Avenue, #D204 Upland, California 91786
Re: K030632
Trade/Device Name: PD Casta-H Regulation Number: 21 CFR 872.3710 Regulation Name: Base Metal Alloy Regulatory Class: II Product Code: EJH Dated: February 26, 2003 Received: February 28, 2003
Dear Ms. Joline:
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. Joline
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. 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 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 Rinner
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
Enclosure
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Page of
| 5:.0(k) NUMBER (IF KNOWN): | K030632 |
|---|---|
| DEVICE NAME: | PD Casta-H |
INDICATIONS FOR USE:
Non-Precious Dental Casting Alloy . Suitable for use in fabrication of removable dental appliances.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.10 OR
Over - The - Counter - Use er The Councern 1-2-96)
Ke Mulay for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Denta
510(k) Number: K030632
§ 872.3710 Base metal alloy.
(a)
Identification. A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” The device is 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.