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510(k) Data Aggregation
K Number
K112333Device Name
LRT ATTACHMENT
Manufacturer
BCF CERTIFICATION INC.
Date Cleared
2012-01-30
(171 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
BCF CERTIFICATION INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LRT Attachment System is indicated for providing a mean of attaching a removable prosthetic device to an endosseous implant body.
Device Description
Alike the Locator implant, the O-ring Prosthetic Attachment and the Nobel Ball Attachment systems, the LRT Attachment System provides a mean for attaching a removable prosthetic device to an endosseous implant body with the use of a mechanical based retention, hence eliminating permanent structures that prevent easy access to implant abutments.
The LRT Attachment System requires the use of two ball abutments to receive the The presence of additional implant abutments, although not attachment. mandatory, contributes to the support and stability of the prosthesis. These abutments are cone shaped and mate with a reciprocal cover in the denture base.
All predicate devices are snap-on devices. The retentive female part is embedded in the denture part and snaps on another part (e.g. a ball abutment). The retentive action relies on the expansion and constriction of the metal female counterpart. The LRT Attachment System provides for an innovative solution by featuring a lock-release retention system activated by digital pressure. This mechanical lock/release action offers ease of manipulation. One of the key elements of the LRT Attachemt System is the easily identified "buttons" of the lock/release mechanism which allow an assistant to manipulate the denture for the severely impaired person.
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