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510(k) Data Aggregation
K Number
K221966Device Name
Dynamic TiBase
Manufacturer
Talladium Espana, SL
Date Cleared
2022-09-15
(72 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
Talladium Espana, SL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dynamic TiBase abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.
Device Description
The purpose of this submission is to obtain marketing clearance for Dynamic TiBase, two-piece titanium base abutments that require the fabrication of patient-specific custom zirconia superstructures using CAD-CAM technology. In final, finished form, the subject device abutments are intended to be used as a two-piece abutment composed of the base bottom-half (titanium base) with a bonded CAD-CAM zirconia top-half. Each patient-specific zirconia superstructure is individually prescribed by the clinician and manufactured by an authorized milling center.
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K Number
K162021Device Name
3.0 Dynamic TiBase
Manufacturer
TALLADIUM ESPANA, SL
Date Cleared
2018-05-04
(652 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
TALLADIUM ESPANA, SL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
3.0 Dynamic TiBase are intended for use with dental implants as a support for multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
Device Description
Not Found
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