BIO 60

K041378 · Kodent, Inc. · EJT · Aug 2, 2004 · Dental

Device Facts

• Record ID: K041378
• Device Name: BIO 60
• Applicant: Kodent, Inc.
• Product Code: EJT · Dental
• Decision Date: Aug 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3060
• Device Class: Class 2

Indications for Use

BIO 60 is intended for use in the fabrication of implant superstructures and gold cylinders for dental implants.

Device Story

BIO 60 is a gold-based alloy used by dental professionals for the fabrication of implant superstructures and gold cylinders. The device serves as a restorative material for dental implants. It is processed by dental technicians or clinicians to create custom prosthetic components. The material properties are designed to meet clinical requirements for dental restorations, providing a stable base for implant-supported prosthetics. The device is intended for prescription use only.

Clinical Evidence

Bench testing only. The device was evaluated for physical and mechanical properties including melting point, hardness, proof strength, coefficient of thermal expansion, and density, compared against the predicate device (Ceramicor). Testing followed ANSI/ADA 5 and ISO 9693 standards.

Technological Characteristics

Gold-based alloy containing Au (60.00%), Pt (15.20%), Pd (24.00%), and In (0.8%). Physical properties: melting point 1,400-1,490°F, hardness 250 Vickers, proof strength 645 N/mm-2, CTE 11.8 x 10-6/°C, density 17.9 g/cm3. Tested per ANSI/ADA 5 and ISO 9693.

Indications for Use

Indicated for use in the fabrication of implant superstructures and gold cylinders for dental implants.

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.

Predicate Devices

• Southern Implants Cylinder

Submission Summary (Full Text)

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AUG - 2 2004

K041378

## 510(K) SUMMARY

| Submitter of 510(k): | KoDent, Inc.<br>9778 Katella Ave. Ste.215, Anaheim, CA 92804<br>Phone: [phone], Fax: [phone] | | | |
|----------------------|----------------------------------------------------------------------------------------------------------|--|--|--|
| Contact person: | Dae Kyu Chang | | | |
| Phone: | [phone] | | | |
| Fax: | [phone] | | | |
| E-mail: | [e-mail] | | | |
| Date of Summary: | May 21, 2004 | | | |
| Trade name: | BIO 60 | | | |
| Common: | Gold cylinder for using UCLA Abutment | | | |
| Classification name: | Gold based alloys and precious metal alloys for clinical use | | | |
| Product code: | EJT | | | |
| Classification: | Class II | | | |

Legally marketed device: Southern Implants Cylinder 510(k) number:

## SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS

Test methods applied: as in ANSI/ADA 5 and ISO 9693

Comparison of composition:

Composition (weight)

| | Au (%) | Pt (%) | Pd (%) | In (%) |
|-----------|--------|--------|--------|--------|
| Ceramicor | 60.00 | 19.00 | 20.00 | 1.0 |
| BIO 60 | 60.00 | 15.20 | 24.00 | 0.8 |

Comparison of physical and mechanical properties:

| Alloy | Melting Point<br>Range (°F) | Hardness<br>(vickers) | Proof<br>Strength<br>(0.2%) | CTE<br>(x10-6/°C) | Density<br>(g/c<br>x103m3) |
|-----------|-----------------------------|-----------------------|-----------------------------|-------------------|----------------------------|
| Ceramicor | 1,475 | 265 | 635N/mm-2 | 12.0 | 18.5 |
| BIO 60 | 1,400-1,490 | 250 | 645N/mm-2 | 11.8 | 17.9 |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling a bird or abstract human figure, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 2 2004

Mr. Dae Kyu Chang Owner Kodent, Incorporated 9778 Katella Avenue, Suite 215 Anaheim, California 92804

Re: K041378

Trade/Device Name: BIO 60 Regulation Number: 21 CFR 872.3060 Regulation Name: Gold Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: May 21, 2004 Received: May 24, 2004

Dear Mr. Chang:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection broky proximally equivalent (for the indications for relerenced above and nave decemined aread predicate devices marketed in interstate commerce use stated in the encreatify management date of the Medical Device Amendments, or to devices that prior to May 26, 1776, the chaemism and the Reseral Food, Drug, and Cosmetic liave been tectassified in acceration of a premarket approval application (PMA). You may, Act (Act) that ao not require apple for the general controls provisions of the Act. The general therefore, market the device, subject to the generation, listing of devices, good Controls provisions of missions and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into existing major regulations affecting your device can be may be subject to such additional controller and to 898. In addition, FDA may publish found in the Sourcerning your device in the Federal Register.

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## Page 2 -- Mr. Dae Kyu Chang

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 's issualled of a sacesting complies with other requirement of the Act of that FDA nas made a ucternmation mar your aed by other Federal agencies. You must comply with any Federal statures and regulations administration of to: registration and listing (21 CFR Part 877); all the Act s requirements, menuding, but nov incenter requirements as set forth in the quality labeling (21 CFR Part 001), good management of and if applicable, the electronic product radiation systems (QS) rogards (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) I ms letter will anow you to oogin mantening of substantial equivalence of your device to a legally prematket notification: "The PDF Intentig sification 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 If you desire specific advice for your a011. Additionally, for questions on the promotion comact the Office of Compliance at [phone] Compliance at [phone]. Also, 1 and advertising of your device, prease corranding by reference to premarket notification" (21CFR please note the regulation entition, "Fasseral information on your responsibilities under the Act may F all 807.77) you they obtain. Other gol 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 vours,

Chiu S. Lin, PhD

Chiu S. Lin, PhD 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

510(k) Number (if known): K041378

Device Name: BIO 60 Indications for Use:

BIO 60 is intended for use in the fabrication of implant superstructures and gold cylinders for dental implants.

Prescription Use X (21 CFR Part 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR Part 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Angela Blackwell for ASR

Division of Anesthesiology, Genera Infection Control, Dental Devices

510(k) Number: K041378

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