STARBOND DENTAL BONDING ALLOYS

K032106 · Star Refining Precious Metals South Africa · EJT · Aug 25, 2003 · Dental

Device Facts

• Record ID: K032106
• Device Name: STARBOND DENTAL BONDING ALLOYS
• Applicant: Star Refining Precious Metals South Africa
• Product Code: EJT · Dental
• Decision Date: Aug 25, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3060
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

STARBOND SISG Porcelain to precious recal ulloy suitable for single units, short and long span bridges for metal ceramics, as well as milled work and implant over structures. STARBOND S250 Porcelain to precious metal alloy suitable for single units, short and long span bridges for metal ceramics, as well as milled work and implant over structures. STARBOND 575P Porcelain to precious metal alloy suitable for single units, short and long span bridges for metal commics, as well as milled work, bars and attachments and cast partial dentures. STARBOND 650SF Porcelain to precious metal alloy suitable for single units, short and long span bridges for metal ceramics, as well as implant over structures. STARBOND 780G Porcelain to presious metal alloy suitable for a wide range of applications including: single units, short and long span bridges for metal ccramics and milled work and implant over structures. STARBOND 860G Porcelain to precious metal alloy surface for Single surface intact inlays, crowns, small and long span bridges as well as crown and bridge fromes for metal ceramics STARBOND 990G Poroclain to precious metal alloy suitable for low stress stuations only, single units with till porcelain coverage.

Device Story

StarBond Dental Bonding Alloys are precious metal-based alloys used by dental technicians and dentists to fabricate dental restorations. These alloys serve as the metallic substructure for porcelain-fused-to-metal (PFM) crowns, bridges, inlays, and implant-supported prosthetics. The alloys are cast or milled into the desired anatomical shape in a dental laboratory setting. Once the metal framework is prepared, the dental professional applies and fires dental porcelain onto the alloy surface to achieve the final aesthetic restoration. The device provides the structural integrity and biocompatible base necessary for long-term oral rehabilitation. Benefits include high strength, durability, and compatibility with standard dental ceramic systems, allowing for the restoration of tooth function and aesthetics in patients requiring fixed or removable prosthodontics.

Clinical Evidence

Bench testing only.

Technological Characteristics

Precious metal-based dental alloys; metallic composition designed for porcelain-fused-to-metal (PFM) applications; physical properties consistent with 21 CFR 872.3060; form factor includes ingots or discs for casting or milling; biocompatible; non-sterile.

Indications for Use

Indicated for dental patients requiring porcelain-to-metal restorations, including single units, crowns, inlays, short/long span bridges, milled work, bars, attachments, cast partial dentures, and implant over-structures.

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

Star Refining Precious Metals South Africa C/O Mr. Ned E. Devine Responsible Third Party Official Entela, Incorporated Engineering and Testing Laboratories 3033 Madison Avenue, SE Grand Rapids, Michigan 49548

Re: K032106

Trade/Device Name: StarBond Dental Bonding Alloys Regulation Number: 872.3060 Regulation Name: Gold-Basted Alloys and precious Metal Alloys for Clinicial Use Regulatory Class: II Product Code: EJT, EJS Dated: August 8, 2003 Received: August 11, 2003

Dear Mr. Devine:

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.

# AUG 2 5 2003

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# Page 2 – Mr. Divine

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 (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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 Kurner

Susan Runner, DDS, MA Interim Direction 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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### 510(k) Number (if known):

# Device Name: Starbond Dental Alloys

# Classification Panel: 872.3060 EJT

# Indications for Use:

STARBOND SISG

Porcelain to precious recal ulloy suitable for single units, short and long span bridges for metal ceramics, as well as milled work and implant over structures.

### STARBOND S250

Porcelain to precious metal alloy suitable for single units, short and long span bridges for metal ceramics, as well as milled work and implant over structures.

#### STARBOND 575P

Porcelain to precious metal alloy suitable for single units, short and long span bridges for metal commics, as well as milled work, bars and attachments and cast partial dentures.

#### STARBOND 650SF

Porcelain to precious metal alloy suitable for single units, short and long span bridges for metal ceramics, as well as implant over structures.

#### STARBOND 780G

Porcelain to presious metal alloy suitable for a wide range of applications including: single units, short and long span bridges for metal ccramics and milled work and implant over structures.

#### STARBOND 860G

Porcelain to precious metal alloy surface for Single surface intact inlays, crowns, small and long span bridges as well as crown and bridge fromes for metal ceramics

#### STARBOND 990G

Poroclain to precious metal alloy suitable for low stress stuations only, single units with till porcelain coverage.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

or

Over the Counter Use _________________________________________________________________________________________________________________________________________________________

Susan Runn

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

510(k) Number: k083211

K032106