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510(k) Data Aggregation
K Number
K061335Device Name
ENHANCE DENTAL IMPLANT SYSTEM
Manufacturer
Date Cleared
2006-08-09
(89 days)
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
COASTAL BIOCARE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Enhance Dental Implant System is intended to be surgically placed in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. It may be placed immediately in an extraction site or may be placed after bone healing.
Device Description
The Enhance Dental Implant System (Enhance System) is a system of threaded root-form dental implants and abutments.
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