AMALCAP PLUS

K982456 · Ab Ardent · EJJ · Aug 24, 1998 · Dental

Device Facts

• Record ID: K982456
• Device Name: AMALCAP PLUS
• Applicant: Ab Ardent
• Product Code: EJJ · Dental
• Decision Date: Aug 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3070
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

AMALCAP PLUS 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.

Device Story

AMALCAP PLUS is a dental filling material used by dentists to restore tooth function following caries removal. It is indicated for direct, fixed restorations including single, two, and three-surface cavities, pinned onlays, half crowns, and core build-ups. The device is intended for professional use only by DDS or DMD practitioners in a clinical setting. It functions as a restorative material to replace lost tooth structure, providing structural support for subsequent crown procedures or direct restoration of the tooth surface.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental restorative filling material. Formulated for direct placement by dental professionals. No specific materials, energy sources, or software components described.

Indications for Use

Indicated for dental patients requiring restoration of teeth with carious lesions, including Class I, two-surface (MO, DO, FO, LO), and three-surface (MOD, 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 4 1998

AB ARDENT C/O Mr. Clyde E. Ingersoll ARDENT PRODUCT DEVELOPMENT 54 Riverview Avenue Tonawanda, New York 14150-5260

Re: K982456 AMALCAP PLUS Trade Name: Regulatory Class: II Product Code: EJJ Dated: July 10, 1998 Received: July 15, 1998

Dear Mr. Ingersoll:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Ingersoll

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 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 requlation entitled, "Misbranding by reference to premarket notification"(21CFR 807.97). "Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

S. Sutron for

Timothy 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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## AB ARDENT

Generatorgatan 8 S-195 60 Marsta Sweden Phone [phone] FAX [phone]

510 (k)

## AMALCAP PLUS

ATTACHMENT #4

## INDICATIONS FOR USE

510(k) Number: number not yet assigned

Device Name: AMALCAP PLUS

AMALCAP PLUS 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.

Susan Runney

and Adversion Cuntrol. and Coractif the phat Covices

510(k) Number: K485456