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510(k) Data Aggregation
K Number
K192839Device Name
DSP Implant System
Manufacturer
D.S.P Industrial Eireli
Date Cleared
2021-02-11
(504 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
D.S.P Industrial Eireli
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DSP Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
Device Description
DSP Implant System is composed of the External Hex (HE) implant line is composed of implants and related prosthetic components available in multiple designs. DSP implants are made of commercially pure titanium (ASTM F67). DSP prosthetic components are made of commercially pure titanium or cobalt-molybdenum alloy (ASTM F1537). DSP implant system screws (abutment and prosthetic screws) are made of titanium alloy (ASTM F136). The HE implant line is named after the External Hex implant-to-abutment interface. It is subdivided in External Hex SLIM (HE SLIM), External Hex BIOFIT), External Hex SOULFIT (HE SOULFIT), External Hex PROPFIT (HE PROPFIT) and External Hex WAYFIT). The HE implants are bone-level implants. The subject device abutments components mate exclusively with the subject implants of the same line.
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