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510(k) Data Aggregation
K Number
K990979Device Name
STECO-TITANMAGNETICS
Manufacturer
STECO-SYSTEM-TECHNIK GMBH & COKG
Date Cleared
1999-09-03
(164 days)
Product Code
EGG
Regulation Number
872.3165Why did this record match?
Applicant Name (Manufacturer) :
**STECO-SYSTEM-TECHNIK GMBH **& COKG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 Description
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