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510(k) Data Aggregation
K Number
K083543Device Name
DENOVISMED DENTAL IMPLANT SYSTEMS
Manufacturer
Date Cleared
2009-03-06
(98 days)
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
DENOVIS MEDICAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For immediate or delayed placement and function on single-tooth and/or multiple tooth applications in the maxillary and or mandibular arches to support crowns, bridges, and overdentures in edentulous or partially edentulous patients. Immediate loading is indicated for single tooth and/or multiple tooth applications when there is good primary stability and an appropriate occlusal load.
Device Description
The DenovisMed Dental Implant System is intended to support prosthetic devices in edentulous or partially edentulous patients to restore esthetics and chewing function. The System consists of the DenovisMed Dental Implant, a self-tapping, threaded, root-formed dental implant as well as straight abutments and related prosthetic components.
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