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510(k) Data Aggregation
K Number
K143758Device Name
PerioType Rapid
Manufacturer
CLINICAL HOUSE EUROPE GMBH
Date Cleared
2015-08-07
(219 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
CLINICAL HOUSE EUROPE GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PerioType Rapid Implants are threaded, root-form dental implants intended for use in the upper and lower jaw to support prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function to partially or fully edentulous patients for loading after healing or immediate loading provided that stability requirements are satisfied.
Device Description
PerioType Rapid Implants are threaded, root-form dental implants
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K Number
K123386Device Name
PERIOTYPE X-PERT
Manufacturer
CLINICAL HOUSE EUROPE GMBH
Date Cleared
2013-04-26
(175 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
CLINICAL HOUSE EUROPE GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PerioType X-Pert Implants are threaded, root-form dental implants intended for use in the upper and lower jaw to support prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function to partially or fully edentulous patients. PerioType X-Pert Dental Implant Systems are indicated for delayed loading.
The PerioType X-Pert Abutments are straight and angled dental implant Abutments to be used in conjunction with the PerioType. X-Pert dental implant fixture to aid in prosthetic rehabilitation.
Device Description
PerioType X-Pert Implants are threaded, root-form dental implants intended for use in the upper and lower jaw to support prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function to partially or fully edentulous patients. PerioType X-Pert Dental Implant Systems are indicated for delayed loading. The Dental Implant System has an internal octagonal connection between the implant and the abutment. The surface structure of the implant is PerioCoat-R which allows for osseointegration of the implants that is substantially equivalent to the TilUnite surface from Nobel Biocare. The Dental Implants and the abutments are made of Titanium Grade 4. The PerioType X-Pert features an implant-abutment interface with a tapered tight metal fit and an integrated platform switch. The abutments are coated with ZircoSeal™ - a hard coating layer of zirconium nitride. The implants are provided sterile, with sterility achieved by gamma radiation pursuant to ISO 11137.
The PerioType X-Pert Abutments are straight and angled dental implant Abutments to be used in conjunction with the PerioType X-Pert dental implant fixture to aid in prosthetic rehabilitation.
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