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510(k) Data Aggregation
K Number
K240725Device Name
PreXolid CAD/CAM abutments
Manufacturer
Date Cleared
2024-10-18
(214 days)
Product Code
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
Eclectic Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
PreXolid CAD/CAM Abutments are intended for use on endosseous dental implants in the edentulous or partially edentulous maxilla or mandible, as an aid in the prosthetic rehabilitation.
Device Description
The subject patient-specific abutment, PreXolid CAD/CAM Abutment used in fabricating fully patient-specific abutments made of Ti-6A1-4V ELI, conforming to ASTM Standard F136. Each patient-specific abutment is individually prescribed by the clinician.
The subject devices are available in diameters ranging from 5.0mm. The subject device is provided with an abutment screw.
PreXolid CAD/CAM Abutments are compatible with XPEED AnyRidge Internal Implant System (K12231).
The allowable ranges of design parameters after CAD/CAM patient-matching are as follows:
Minimum wall thickness(mm): 0.45
Maximum angulation(°): 25
Minimum gingival collar height(mm): 2.00
Maximum gingival collar height(mm): 5.00
Minimum gingival collar(ø): 4.00
Maximum gingival collar(ø): 9.50 , 11.50
Minimum post height (mm): 4.00
Maximum post height (mm): 6.00
The subject abutments are provided non-sterile and are intended to be sterilized by the clinician.
Materials:
Pre-milled abutments and screws are fabricated from Ti-6A1-4V ELI, conforming to ASTM Standard F136.
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