CERANUM 82

K023197 · Sb Lucius, Inc. · EJT · Nov 5, 2002 · Dental

Device Facts

• Record ID: K023197
• Device Name: CERANUM 82
• Applicant: Sb Lucius, Inc.
• Product Code: EJT · Dental
• Decision Date: Nov 5, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3060
• Device Class: Class 2

Intended Use

CERANUM 82 is intended for manufacturing: - Single Crown - - Bridges - - Implant superstructures

Device Story

Ceranum 82 is a high noble, micro-fine, yellow, gold-based dental casting alloy. It serves as a substrate for medium expansion with lower fusing porcelains and indirect restorative composites. Used by dental professionals in the fabrication of single crowns, bridges, and implant superstructures. The alloy provides structural strength, durability, and the aesthetic color of gold for dental restorations. It is processed via standard dental casting techniques.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing of physical and mechanical properties (melting point, hardness, yield strength, elongation, CTE, density) and compositional analysis compared to the predicate device, following ANSI/ADA 5 and ISO 9693 standards.

Technological Characteristics

High noble, gold-based dental casting alloy. Composition: Au 82%, Pt 8.87%, Pd 3.8%, In 2.0%, Ir 0.1%, Ta 0.25%. Physical properties: Melting range 2,192-2,372°F, Vickers hardness 165, yield strength 320 MPa, elongation 9.3%, CTE 14.1 x 10^-6/°C, density 19.2 g/cm3. Tested per ANSI/ADA 5 and ISO 9693.

Indications for Use

Indicated for use in the fabrication of single crowns, bridges, and implant superstructures as a high noble, gold-based ceramic alloy for dental restorations.

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

• Metalor's V-Supragold (K993508)

Submission Summary (Full Text)

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5 2002 NOV

K023197

# 510(K) SUMMARY

SB LUCIUS, INC. Submitter of 510(k): Ste.205, Anaheim, CA 92804 9778 Katella Ave. Phone: [phone], Fax : [phone],

| Contact person: | Dae Kyu Chang |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Phone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| Date of Summary: | Sept. 16, 2002 |
| Trade name:<br>Common:<br>Classification name: | CERANUM 82<br>Dental casting alloy<br>Gold based alloys and precious metal alloys for<br>clinical use |
| Product code: | EJT |
| Classification: | Class II |

Legally marketed device: Metalor's V-Supragold 510(k) number: K993508

# SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS

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

# Comparison of composition:

| Device Name | Au (%) | Pt (%) | Pd (%) | In (%) | Ir | Ta |
|-------------|--------|--------|--------|--------|-------|-------|
| V-Supragold | 83.00 | 8.8 | 5.20 | 2.8 | <1.0% | <1.0% |
| Ceranum 82 | 82.00 | 8.87 | 3.8 | 2.0 | 0.1 | 0.25 |

### COMPOSITION (WEIGHT, %)

## Comparison of physical and mechanical properties:

| Alloy | Melting Point Range (°F) | Hardness (Vickers) | Yield Strength (MPa) | Elongation (%) | CTE (x10-6/°C) | Density (g/cm3) |
|-------------|--------------------------|--------------------|----------------------|----------------|----------------|-----------------|
| V-Supragold | 2,012-2,210 | 190 | 425 | 7.0 | 14.3 | |
| Ceranum 82 | 2,192-2,372 | 165 | 320 | 9.3 | 14.1 | 19.2 |

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### Discussion:

Since the composition of the legally marketed alloy and the new device is very similar, it may be assumed that the biological compatibility of the alloys is also very similar.

### Conclusion:

The main elements and their concentration are almost identical. CERANUM 82 is a High Noble, Micro-fine, Yellow, Gold based alloy to be used for single crowns, bridge, implant superstructures and substrate for medium expansion with lower fusing porcelains and indirect restorative composites. CERANUM 82 is a high gold ceramic alloy, which heightens the porcelain esthetics of the restoration and provides strength, durability and color of gold. Despite minor differences in the materials, we believe that CERAUM 82 is a substantially equivalent to Metalor's V-Supragold . These changes do not affect safety or effectiveness.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Dae-Kyu Chang SB Lucius. Incorporated 9778 Katella Avenue, Suite 205 Anaheim. California 92804

Re: K023197

Trade/Device Name: Ceranum 82 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: September 16, 2002 Received: September 25, 2002

5 2002

Dear Mr. Chang:

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.

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.

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Page 2 -- Mr. Chang

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 (OS) 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 and additionally 21 CFR Part 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" (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 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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9778 Katella Ave.

Ste, 205, Anaheim, CA 92804

Phone: [phone]

# INDICATIONS FOR USE

510(K) Number : K023197

Device Name(s) : ceranum 82

CERANUM 82 is intended for manufacturing:

- Single Crown -
- Bridges -
- Implant superstructures

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

CONCURRENCE OF CHRD,OFFICE OF DEVICE EVALUATION(OED)

K.Schatz DDE/for Div. S. Kummer
(Division Sign Off)

Division of Anesthesiology, General Hospital, tion Control, Dental De

510(k) Number. KC23197