# K990979: Steco-Titanmagnetics

- Pathway: 510(k) (Traditional)
- Applicant: Steco-System-Technik GmbH & Cokg
- Decided: Sep 3, 1999 after 164 days
- Product code: EGG (Attachment, Precision, All)
- Device class: 1
- Regulation: 21 CFR 872.3165
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
General: Titanmagnetics are allowed to be used only in responsibility of a physician, dentist or maxillo-facial surgeon for following indications: Gero-prosthetics Magnet attachment adaptable to different implants or root caps (post). Anchoring of hybrid and partial dentures in category n° III (toothless jaw) and category n° IIc (very few teeth left). The classification is according to the BDIZ-Expert Committee 1997. For lower jaw (mandible) treatments belonging to category n° III; at least 2 to 4 implants shall be inserted, in the upper jaw (maxilla) at least 3 or 4 implants.

Source page: https://510kreport.com/device/K990979
Methodology: https://510kreport.com/methodology