Search Results
Found 1 results
510(k) Data Aggregation
K Number
K052823Device Name
IMPLANTIUM ABUTMENTS
Manufacturer
DENTIUM, INC.
Date Cleared
2006-02-21
(140 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
DENTIUM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Implantium abutments are intended to be used with the Implantium root-form endosseous dental implant to aid in prosthetic rehabilitation including overdenture retention. After the root-form endosseous dental implant is surgically placed, the endosseous dental implant abutment device is attached to it.
Device Description
The Implantium abutments are devices made of pure titanium, titanium alloys, and plastic. The abutments in this 510(k) submission are supplemental to the previously cleared Implantium devices (K041368) and are designed to be used with the Implantium fixtures. These abutments are placed in the fixtures as a support for fitting prosthetic teeth. This submission includes four differently sized ball abutment kits for overdenture retention, and six different temporary abutments for placement of temporary restorations.
Ask a Question
Page 1 of 1