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510(k) Data Aggregation
K Number
K963520Device Name
IMZ TWIN PLUS SCREW
Manufacturer
Date Cleared
1997-08-12
(343 days)
Product Code
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
IMZ, GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
IMZ implants are indicated for single tooth replacement, as immediate abutments on long span to bridgework, as distal abutments on free-end edentulousareas to be restored with fixed arches, and es and es a loss to totally or partially edentulous arches, and as abutments supporting a full arch fixed prosthesis in the totally edentulous mandible or maxila.
Device Description
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K Number
K963521Device Name
IMZ TWIN PLUS - CYLINDER
Manufacturer
Date Cleared
1997-08-06
(337 days)
Product Code
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
IMZ, GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
IMZ implants are indicated for single tooth replacement, as immediate abutments on long span to bridgework, as distal abutments on free-end edentulousareas to be restored with fixed bridgework, to support overdentures in totally or partially edentulous arches, and as abutments supporting a full arch fixed prosthesis in the totally edentulous mandible or maxila.
Device Description
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K Number
K963495Device Name
IMZ 2000 INTERLOCK 12/3 - CYLINDER DENTAL IMPLANT SYSTEM
Manufacturer
Date Cleared
1997-03-03
(181 days)
Product Code
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
IMZ, GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K963522Device Name
IMZ 2000 INTERLOCK 12/3 - SCREW
Manufacturer
Date Cleared
1997-03-03
(181 days)
Product Code
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
IMZ, GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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