SOWELL NICKEL-CHROME NON-PRECIOUS METAL ALLOY

K973568 · C.K. International Trading · EJH · Dec 11, 1997 · Dental

Device Facts

• Record ID: K973568
• Device Name: SOWELL NICKEL-CHROME NON-PRECIOUS METAL ALLOY
• Applicant: C.K. International Trading
• Product Code: EJH · Dental
• Decision Date: Dec 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3710
• Device Class: Class 2

Intended Use

NON-PRECIOUS METAL ALLOY FOR VENEERS, CROWNS, BRIDGES, INLAYS, ONLAYS.

Device Story

Sowell Nickel-Chrome Non-Precious Metal Alloy is a dental casting alloy used by dental laboratories and clinicians to fabricate fixed dental prosthetics. The alloy is processed via standard dental casting techniques to create crowns, bridges, inlays, onlays, and veneers. It serves as a structural material for dental restorations, providing the necessary mechanical properties for long-term oral use. The device is intended for prescription use only.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nickel-chrome based non-precious metal alloy. Formulated for dental casting applications (crowns, bridges, inlays, onlays, veneers).

Indications for Use

Indicated for use in the fabrication of dental restorations including veneers, crowns, bridges, inlays, and onlays.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Anna Chin Distributor C.K. International Trading 2807 Holly Avenue Arcadia, California 91007

DEC I I 1997

Re : K973568 Trade Name: Sowell Nickel-Chrome Non-Precious Metal Alloy Regulatory Class: II Product Code: EJH Dated: September 16, 1997 September 19, 1997 Received:

Dear Ms. Chin:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Ms. Chin

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gow/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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Page__________________________________________________________________________________________________________________________________________________________________________

K973568 510(k) Number (if known):

NICKEL-CHROME NON-PRECIOUS METAL ALLOY Device Name:

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Indications For Use: NON-PRECIOUS METAL ALLOY FOR VENEERS, CROWNS, BRIDGES, INLAYS, ONLAYS.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED!

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices પ્ર 510(k) Number _ 56

Prescription Use (Per 21 CFR 801.109)

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Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)