BEGOPAL 300

K983081 · Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO · EJS · Oct 28, 1998 · Dental

Device Facts

• Record ID: K983081
• Device Name: BEGOPAL 300
• Applicant: Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO
• Product Code: EJS · Dental
• Decision Date: Oct 28, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BegoPal 300 is a crown and bridge metal to ceramic type 4 alloy. It is a medical device in accordance with Regulation 93/42 EEG. Class IIa according to Annex IX. The CE seal accordance with Regulation 95712 22 01 - She Fact that the regulaiton requirements are met.

Device Story

BegoPal 300 is a type 4 dental alloy used for crown and bridge restorations. It is designed for metal-to-ceramic applications. The device is intended for use by dental professionals in a clinical or laboratory setting to fabricate dental prosthetics. It functions as a restorative material to replace missing tooth structure or support dental crowns and bridges. The alloy provides the necessary mechanical properties for dental restorations, benefiting patients by restoring oral function and aesthetics.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Type 4 dental alloy for crown and bridge metal-to-ceramic applications. Classified as Class IIa medical device under Annex IX of Regulation 93/42/EEC.

Indications for Use

Indicated for use as a type 4 crown and bridge metal-to-ceramic alloy for dental restorative procedures.

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 8 1998

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

Re : K983081 Trade Name: BegoPal 300 Requlatory Class: II Product Code: EJS Dated: August 17, 1998 Received: September 2, 1998

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 abe Beach in the enough, 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 Requlations, Title 21, Parts 800 to 895. ਜ 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 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 described in your sia ... quivalence of your device to a legally rinding of babbum device results in a classification for your marketed predication of mits 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 che 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 Information on your 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,

Timo iv 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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K983081 510(k) Number (if known): BegoPal 300

Device Name: _________________________________________________________________________________________________________________________________________________________________ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Indications For Use:

. 1

BegoPal 300 is a crown and bridge metal to ceramic type 4 alloy. It is a medical device in Begoral 300 is a crown and bridge metal to corainle of per uses of annex IX. The CE seal
accordance with Regulation 93/42 EEG. Class IIa according to Annex IX. The CE seal accordance with Regulation 95712 22 01 - She Fact that the regulaiton requirements are met.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div> <p>Susan Pinner</p> <p>(Division Sign-Off)</p> <p>Division of Dental, Infection Control, and General Hospital Devices</p> </div> |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K983081 |

| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---------------------------------------|----|--------------------------|
| | | (Optional Format 1-2-96) |

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