HIGH SILVER CONVENTIONAL

K020452 · Ab Ardent · EJJ · May 7, 2002 · Dental

Device Facts

• Record ID: K020452
• Device Name: HIGH SILVER CONVENTIONAL
• Applicant: Ab Ardent
• Product Code: EJJ · Dental
• Decision Date: May 7, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3070
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

HIGH SILVER CONVENTIONAL is to be used as a filling material for restoring function to teeth which have lost portions to caries: Direct, fixed restorations, placed by the dentist after removal of carious tissue. Single surface cavities such as Class I Two surface cavities such as MO, DO, FO, LO Three surface cavities such as MOD, FOD. Pinned onlays and half crowns. Core build-ups for cast half and full crowns. For use only by dental professional such as DDS or DMD. Not for use by general public or OTC. Labels will bear this caution.

Device Story

High Silver Conventional is a dental amalgam alloy used as a restorative filling material. It is applied by dentists to restore tooth function following the removal of carious tissue. The material is indicated for direct, fixed restorations including single, two, and three-surface cavities, pinned onlays, half crowns, and core build-ups. It is intended exclusively for professional dental use and is not for over-the-counter or public use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Amalgam alloy filling material. Class II device (21 CFR 872.3050).

Indications for Use

Indicated for dental patients requiring restoration of teeth with carious lesions, including Class I, MO, DO, FO, LO, MOD, and FOD cavities, pinned onlays, half crowns, and core build-ups for cast crowns. For use by dental professionals (DDS/DMD) only.

Regulatory Classification

Identification

Dental amalgam is a device that consists of a combination of elemental mercury, supplied as a liquid in bulk, sachet, or predosed capsule form, and amalgam alloy composed primarily of silver, tin, and copper, supplied as a powder in bulk, tablet, or predosed capsule form, for the direct filling of carious lesions or structural defects in teeth. This device also includes the individual component devices, mercury and amalgam alloy, when intended to be combined with each other to form dental amalgam.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy.”*See* § 872.1(e) for the availability of this guidance document.

Submission Summary (Full Text)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 0 7 2002

AB Ardent C/O Mr. Clyde E. Ingersoll Ardent Product Development Tonawanda, New York 14150-5260

Re: K020452

Trade/Device Name: High Silver Conventional Regulation Number: 872.3050 Regulation Name: Amalgam Alloy Regulatory Class: II Product Code: EJJ Dated: January 21, 2002 Received: February 11, 2002

Dear Mr. Ingersoll:

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. Ingersoll

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 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timber 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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ARDENT

K *0 20452

#### HIGH SILVER CONVENTIONAL 510 (k)

ATTACHMENT #4

6

## INDICATIONS FOR USE

510(k) Number: number not yet assigned

Device Name: HIGH SILVER CONVENTIONAL

HIGH SILVER CONVENTIONAL is to be used as a filling material for restoring function to teeth which have lost portions to caries:

Direct, fixed restorations, placed by the dentist after removal of carious tissue.

Single surface cavities such as Class I

Two surface cavities such as MO, DO, FO, LO

Three surface cavities such as MOD, FOD.

Pinned onlays and half crowns.

Core build-ups for cast half and full crowns.

For use only by dental professional such as DDS or DMD. Not for use by general public or OTC.

Labels will bear this caution.

Sumit Kumar

(Division Sign-Off) Division of Dental, Infection Control, Envision of Deman Misolion of Sevices
and General Hospital Devicess
51Olk) Number 510(k) Number _