BIOLOY

K023477 · Neirynck & Vogt NV · EJH · Dec 13, 2002 · Dental

Device Facts

• Record ID: K023477
• Device Name: BIOLOY
• Applicant: Neirynck & Vogt NV
• Product Code: EJH · Dental
• Decision Date: Dec 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3710
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Bioloy alloy is intended to be used by dentists and dental laboratories for the fabrication of custom made dental devices such as onlays, ¼ crowns, veneers, inlays and PFM restorations.

Device Story

Bioloy is a base metal alloy used by dental professionals and laboratories to fabricate custom dental prosthetics. The alloy serves as a structural material for onlays, crowns, veneers, inlays, and PFM restorations. It is processed by dental technicians using standard casting or milling techniques to create the final restoration shape. Once fabricated, the dentist places the device in the patient's mouth to restore tooth function and aesthetics. The device provides a durable, biocompatible framework for dental restorations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Base metal alloy for dental restorations. Classified as Class II under 21 CFR 872.3710. Product code EJH.

Indications for Use

Indicated for use by dentists and dental laboratories for the fabrication of custom dental restorations, including onlays, 1/4 crowns, veneers, inlays, and porcelain-fused-to-metal (PFM) restorations.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three overlapping profiles facing to the right, suggesting a sense of community and support.

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

Neirynck & Vogt NV C/O Mr. Josh Andrachek Vacalon Company, Incorporated 12960 Stonecreek Drive, Suite C Pickerington, Ohio 43147

Re: K023477

Trade/Device Name: Bioloy Regulation Number: 21 CFR 872.3710 Regulation Name: Base Metal Alloy Regulatory Class: II Product Code: EJH Dated: September 23, 2002 Received: October 16, 2002

Dear Mr. Andrachek:

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. Josh Andrachek

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). 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,

Timothy A. Ulatowski

Timbthy A. Ulatowski 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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## Indications for Use

l of Page

510(k) Number (if known): KO23477

Device Name: Bioloy

.

Indications for Use:

Bioloy alloy is intended to be used by dentists and dental laboratories for the fabrication of custom made dental devices such as onlays, ¼ crowns, veneers, inlays and PFM restorations.

(Please do not write below this line- Continue on another page if needed)

Prescription Use V (Per 21 CFR 801-109)

OR

Over-the-counter Use

(optional; format 1-2-96)

Susan Runne

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

510(k) Number .