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510(k) Data Aggregation
K Number
K091390Device Name
HDC STERILE SELF LIGATING SPIDER SCREW, MODEL SLI,SL2
Manufacturer
HDC S.R.L.
Date Cleared
2009-07-30
(80 days)
Product Code
OAT, REG
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
HDC S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sterile Self Ligating Spider Screw is a threaded titanium dental implant screw, intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. The device is used temporarily and shall be removed after orthodontic treatment has been completed. It is provided sterile and is intended for single use only.
Device Description
The Sterile Self Ligating Spider Screw is a titanium fixation device to be inserted into the upper or lower jaws, designed to be immediately used (after the bone insertion) as fixation for orthodontic appliances. It is used temporarily and must be removed after the orthodontic treatment has been completed. It is provided sterile and is intended for single use only. The Sterile Self Ligating Spider Screw is provided in "Self Drilling and Self Tapping" configuration and is manufactured from Grade 5 Titanium alloy according to ASTM F136-98 standard. Sterile Self Ligating Spider Screw is provided with different diameters. lengths and head shapes.
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K Number
K071851Device Name
HDC STERILE SPIDER SCREW
Manufacturer
HDC S.R.L.
Date Cleared
2007-10-18
(105 days)
Product Code
DZE, OAT
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
HDC S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HDC Sterile Spider Screw is a threaded titanium dental implant screw, intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. It is used temporarily and must be removed after the orthodontic treatment has been completed. It is provided sterile and is intended for single use only.
Device Description
The HDC Sterile Spider Screw is a titanium fixation device to be inserted into the upper or lower jaws. designed to be immediately used (after the bone insertion) as fixation for orthodontic appliances. It is used temporarily and must be removed after the orthodontic treatment has been completed. It is provided sterile and is intended for single use only. The Sterile Spider Screw is provided in two configuration "Self Tapping" and "Self Drilling and Self Tapping." Self Tapping Spider Screw is manufactured from ASTM F67 and ASTM F136. Self Drilling and Self Tapping Spider Screw is manufactured from ASTM F136. HDC Sterile Spider Screw is provided in three tip size diameters: 1.3 mm, 1.5 mm and 2.0 mm.
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K Number
K052471Device Name
HDC SPIDER SCREW
Manufacturer
HDC S.R.L.
Date Cleared
2005-12-23
(106 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
HDC S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HDC Spider Screw is a threaded titanium dental implant screw, intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. The device is used temporarily and shall be removed after orthodontic treatment.
Device Description
The HDC Spider Screws are titanium fixation devices to be inserted into the upper or lower jaws, designed to be immediately used (after the bone insertion) as fixation for orthodontic appliances. Spider Screws are provided in two configuration "Self Tapping" and "Self Drilling and Self Tapping." Self Tapping Spider Screws are manufactured from ASTM F67. Self Drilling and Self Tapping Spider Screws are manufactured from ASTM F136. The HDC Spider Screws are provided in two tip size diameters, 1.5 mm and 2.0 mm. These devices are provided non-sterile and must be sterilized prior to use.
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