Search Results
Found 1 results
510(k) Data Aggregation
K Number
K073116Device Name
EBI INTERNAL IMPLANT SYSTEM
Manufacturer
EBI, INC.
Date Cleared
2008-02-28
(115 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
EBI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges or overdentures in edentulous or partially edentulous patients.
Device Description
The EBI Internal Implant system is a threaded, root form endosseous implant comprised of an internal octagon, 8° morse tapered device manufactured from pure Titanium ASTM F-67 and the Abutment from Titanium 6A-4V alloy E 11 -ASTM 136. The implant's external threaded surfaces are roughened to facilitate tissue and bone integration. The implant's self-tapping feature may be used with or without pre-tapping the bone. System components for restorative purposes include: screw retained and cement retained abutments, cover screws, healing abutments, and angled abutments.
Ask a Question
Page 1 of 1