CERACAST-V

K030416 · Mountain Medico, Inc. · EJH · Apr 14, 2003 · Dental

Device Facts

• Record ID: K030416
• Device Name: CERACAST-V
• Applicant: Mountain Medico, Inc.
• Product Code: EJH · Dental
• Decision Date: Apr 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3710
• Device Class: Class 2

Intended Use

Non-Precious Dental Casting Alloy. Suitable for use in the fabrication of Ceramic Fused to Metal (metallo-ceramic) dental restorations.

Device Story

Ceracast-V is a non-precious dental casting alloy used by dental laboratory technicians to fabricate metallo-ceramic dental restorations. The alloy serves as the metallic substructure onto which dental ceramic is fused. It is intended for professional use in dental laboratory settings to create crowns, bridges, or other prosthetic restorations. The device provides the structural foundation for the final dental restoration, benefiting patients by enabling the creation of durable, aesthetic tooth replacements.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Base metal alloy for dental casting. Classified under 21 CFR 872.3710, Product Code EJH.

Indications for Use

Indicated for use in the fabrication of ceramic fused to metal (metallo-ceramic) dental restorations. Prescription use only.

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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Image /page/0/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized human figure with three wavy lines extending from its body, representing care and support.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 4 2003

Dr. Paul C. Chang President Mountain Medico, Incorporated 600 North Mountain Avenue, #D204 Upland, California 91786

Re: K030416

Trade/Device Name: Ceracast-V Regulation Number: 21 CFR 872.3710 Regulation Name: Base Metal Alloy Regulatory Class: II Product Codes: EJH Dated: February 05, 2003 Received: February 10, 2003

Dear Dr. Chang:

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 vour 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 - Dr. Paul C. Chang

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 [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" (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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Moore

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): KO30416

Device Name: Ceracast-V

Indicalions For Use:

Non-Precious Dental Casting Alloy. Suitable for use in the fabrication of Ceramic Fused to Metal (metallo-ceramic) dental restorations.

> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PA NEEDED)

> > Concurrence of CDRH, Olfice of Device Evaluation (ODE)

| Prescription Use | X (Per 21 CFR 801.109) |
|------------------|------------------------|
|------------------|------------------------|

OR

| Division Sign-Off | Kerry MSR |
|-------------------|---------------------------------------------------------------------------------|
| | Division of Anesthesiology, General Hospital, Infection Control, Dental Devices |

| Over-The-Counter Use | (Optional Forma |
|----------------------|-----------------|
|----------------------|-----------------|

| 510(k) Number: | K030416 |
|----------------|---------|
|----------------|---------|