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510(k) Data Aggregation
K Number
K092507Device Name
ZIT-Z
Manufacturer
Date Cleared
2010-05-11
(267 days)
Product Code
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
ZITERION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Zit-z dental implants are root-form endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. They are indicated for single or multiple unit restorations in splinted or non-splinted applications. The zit-z dental implants are restored with fixed/cemented crowns and bridges. Not for immediate loading.
The 3.5mm implant is contraindicated for restorations of the posterior teeth in the upper or lower jaw and for single-tooth restoration of canines and central incisors in the upper jaw.
Device Description
Zit-z Dental Implant System is a root-form dental implant system with a one-piece cylindrical screw implant design. They have a pentagonal geometry anti-rotation feature which also provides ease of insertion. They are made from HIP zirconium dioxide ceramics (3Y-TZP) which meets (SO 13356.
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