PLATINLLOYD 100

K983079 · Bego U.S.A. · EJT · Oct 23, 1998 · Dental

Device Facts

• Record ID: K983079
• Device Name: PLATINLLOYD 100
• Applicant: Bego U.S.A.
• Product Code: EJT · Dental
• Decision Date: Oct 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PlatinLloyd 100 is : crown and bridge type 4 casting alloy. It is a medical device in PlatinLloyd 100 is ? Crown and online components to Annex IX. The CE seal accordance with Regulation 93/42 EEC. Class IIa according to Annex IX. The CE seal accordance with Regulation 75/42 BEO. Class and were and

Device Story

PlatinLloyd 100 is a type 4 dental casting alloy used by dental professionals for the fabrication of crowns and bridges. The device is a metallic material intended for dental restoration. It is used in a clinical or laboratory setting by dentists or dental technicians to create prosthetic dental components. The alloy provides the structural material for the final restoration, which is then placed in the patient's mouth to restore dental function and aesthetics.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Type 4 dental casting alloy. Form factor: casting alloy for dental restorations. Intended for use in crown and bridge applications.

Indications for Use

Indicated for use as a type 4 casting alloy for the fabrication of dental crowns and bridges.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 3 1998

Mr. William J. Oremus General Manager BEGO U.S.A., Incorporated 1088 Main Street, Suite 200 Pawtucket, Rhode Island 02860

K983079 Re : PlatinLloyd 100 Trade Name: Requlatory Class: II Product Code: EJT August 17, 1998 Dated: September 2, 1998 Received:

Dear Mr. Oremus:

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 aqainst 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 Requlations, 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 requlation 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Oremus

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 requlation (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.gov/cdrh/dsmamain.html".

Sincerely yours,

Patrux Cuente/foc

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K983079 510(k) Number (if known):

PlatinLloyd 100 Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

PlatinLloyd 100 is : crown and bridge type 4 casting alloy. It is a medical device in PlatinLloyd 100 is ? Crown and online components to Annex IX. The CE seal
accordance with Regulation 93/42 EEC. Class IIa according to Annex IX. The CE seal accordance with Regulation 75/42 BEO. Class and were and

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(D
Division
and General
510(k) Number

Prescription Use ✓
(Per 21 CFR 801.109)

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