ALEXANDER

K032493 · Ivoclar Vivadent, Inc. · EJT · Sep 4, 2003 · Dental

Device Facts

• Record ID: K032493
• Device Name: ALEXANDER
• Applicant: Ivoclar Vivadent, Inc.
• Product Code: EJT · Dental
• Decision Date: Sep 4, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3060
• Device Class: Class 2

Intended Use

Alexander alloy intended to be used for inlays, onlays, ¾ crowns, telescope crowns, conus crowns, posts, short and long span bridges, PFM crowns, and partial dentures.

Device Story

Alexander is a dental casting alloy used by dental professionals for fabrication of various dental restorations; including inlays, onlays, crowns, posts, bridges, and partial dentures. Device functions as restorative material in dental laboratory settings. No electronic, software, or algorithmic components involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Gold-based alloy; precious metal alloy for dental clinical use. Classified as Class II, Product Code EJT. No software, energy source, or connectivity features.

Indications for Use

Indicated for dental patients requiring restorative procedures including inlays, onlays, crowns (3/4, telescope, conus, PFM), posts, bridges (short/long span), and partial dentures.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

SEP = 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Anderjeet S. Gulati Quality Assurance Manager Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228

Re: K032493

Trade/Device Name: Alexander Regulation Number: 872.3060 Regulation Name: Gold-Basted Alloys and precious Metal Alloys for Clinical USE Regulatory Class: II Product Code: EJT Dated: August 8, 2003 Received: August 16, 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. Gulatl

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

Sincerely yours,

Susan Runore

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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| 510(k) Number (if known): | K032493 |
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Device Name:

Alexander

Indications For Use:

Alexander alloy intended to be used for inlays, onlays, ¾ crowns, telescope crowns, conus crowns, posts, short and long span bridges, PFM crowns, and partial dentures.

Kein Muluy for MSR

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K032493

(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 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR

(Optional Format 1-2-96)