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510(k) Data Aggregation
K Number
K034067Device Name
ZTI IMPLANTS SYSTEM, DRM IMPLANTS
Manufacturer
Date Cleared
2004-03-08
(68 days)
Product Code
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
DRM RESEARCH LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The permanent post-type implants of this system are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.
The temporary implants are intended to provide immediate transitional splinting stability or fixation of new or existing crown, bridge and denture installations in partially or fully edentulous patients. It is indicated for a maximum of one year.
Device Description
The ZTI Implants System implants are post-type endosseous dental implants with design and manufacturing concepts, materials, surgical procedures, and intended uses quite similar to the preamendment device and to others rated substantially equivalent to the preamendment device. The ZTI Implants system is most similar to the Straumann ITI Implants System which received concurrence of substantial equivalence from the Food and Drug Administration in premarket notification submission K-955281 and the ITI TE "" system in general. Like many commercial implants, the ZTI devices are manufactured of high-purity (99+%) titanium, or titanium alloy (ASTM F 136-84 titanium - 6 aluminum - 4 vanadium)..
ZTI Implants also are available in coated form, either hydroxyapatite or titanium plasma spray, These devices are equivalent to various coated endosseous implants on the market, for example the Sabertech implants of Genentech, Inc., which were cleared under K-924112 and the Crystal-Seal Implants of Crystal Technology, cleared under K-980447.
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