STECO-TITANMAGNETICS

K990979 · Steco-System-Technik GmbH & Cokg · EGG · Sep 3, 1999 · Dental

Device Facts

• Record ID: K990979
• Device Name: STECO-TITANMAGNETICS
• Applicant: Steco-System-Technik GmbH & Cokg
• Product Code: EGG · Dental
• Decision Date: Sep 3, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3165
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Titanmagnetics are allowed to be used only in responsibility of a physician, dentist or maxillofacial surgeon for following indications: Gero-prosthetics Magnet attachment adaptable to different implants or root caps (post). Anchoring of hybrid and partial dentures in category nº III (toothless jaw) and category nº IIc (very few teeth left). The classification is according to the BDIZ-Expert Commitee 1997. For lower jaw (mandible) treatments belonging to category nº III; at least 2 to 4 implants shall be inserted, in the upper jaw (maxilla) at least 3 or 4 implants.

Device Story

Steco-Titanmagnetics are dental magnetic attachment systems used for anchoring hybrid and partial dentures. The device consists of magnets adaptable to dental implants or root caps (posts). Used by dentists, physicians, or maxillofacial surgeons in a clinical setting to stabilize prosthetics in patients with significant tooth loss. The magnetic connection provides retention for dentures, improving prosthetic stability and patient function. The device is a mechanical attachment system; it does not involve electronic processing or software.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Magnetic dental attachment system for prosthetic anchoring. Components are designed for adaptation to dental implants or root caps. Materials are titanium-based (implants/caps) and magnetic alloys. Mechanical retention principle. No software, electronics, or energy source.

Indications for Use

Indicated for gero-prosthetics, specifically anchoring hybrid and partial dentures in patients with toothless jaws (category III) or very few remaining teeth (category IIc). Requires 2-4 implants in the mandible or 3-4 implants in the maxilla.

Regulatory Classification

Identification

A precision attachment or preformed bar is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended for use in prosthetic dentistry in conjunction with removable partial dentures. Various forms of the device are intended to connect a lower partial denture with another lower partial denture, to connect an upper partial denture with another upper partial denture, to connect either an upper or lower partial denture to a tooth or a crown, or to connect a fixed bridge to a partial denture.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 1999 SEP

Steco-System-Technik GmbH & CoKG C/O Dr. rer. nat. Jorn Probst ZMK-Clinic, Department of Experimental Dentistry Pleicherwall 2 97070 Wurzburg, Bavaria GERMANY

Re : K990979 Steco-Titanmagnetics Trade Name: Regulatory Class: I Product Code: EGG Dated: August 13, 1999 Received: August 20, 1999

Dear Dr. Probst:

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 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 through 542 of

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Page 2 - Dr. Probst

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 regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 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.gov/cdrh/dsmamain.html".

Sincerely yours,

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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K 990979 510 (k) Number:

Device Name:

STECO-TITANMAGNETICS

Indications For Use:

General:

Titanmagnetics are allowed to be used only in responsibility of a physician, dentist or maxillofacial surgeon for following indications:

## Gero-prosthetics

Magnet attachment adaptable to different implants or root caps (post). Anchoring of hybrid and partial dentures in category nº III (toothless jaw) and category nº IIc (very few teeth left). The classification is according to the BDIZ-Expert Commitee 1997. For lower jaw (mandible) treatments belonging to category nº III; at least 2 to 4 implants shall be inserted, in the upper jaw (maxilla) at least 3 or 4 implants.

Susar Runa

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number
Ka10979

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ (Per 21 CFR 801.109)

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OR

Over-The-Counter Use