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510(k) Data Aggregation
K Number
K161857Device Name
Salvin Tenting Screw System
Manufacturer
Salvin Dental Specialties
Date Cleared
2017-04-28
(296 days)
Product Code
DZL
Regulation Number
872.4880Why did this record match?
Applicant Name (Manufacturer) :
Salvin Dental Specialties
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Salvin Tenting Screw System is used to stabilize, fixate, and/or support bone filling materials and /or barrier membranes used for regeneration of bone in the oral cavity.
Device Description
The Salvin Tenting Screw System is a set of bone screws and instrumentation. The system consists of a set of screws (one diameter and three lengths) and the driver used to implant these screws. The devices are delivered non-sterile. The screws are made from titanium alloy (Ti-6Al-4V ELI), as described by ASTM F136. The screws come in one diameter – 1.5mm (5.0mm head diameter), and three lengths – 7mm, 8mm, and 9mm. The screws incorporate a 4mm thread length adjacent to a polished neck.
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K Number
K160493Device Name
Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm
Manufacturer
Salvin Dental Specialties
Date Cleared
2016-09-08
(199 days)
Product Code
NPK
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
Salvin Dental Specialties
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Salvin CytoSurg™ Non-Resorbable PTFE Membrane is a temporarily implantable material (nonresorbable) for use as a space-making barrier in the treatment of periodontal defects.
Device Description
The Salvin CytoSurg™ Non-Resorbable PTFE Membrane is composed of microporous PTFE material. It has a nominal thickness of 250 microns and is supplied in two sizes (25mm x 30mm and 12mm x 24mm). The membranes are single use and are supplied in sterile sealed pouches.
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K Number
K100182Device Name
SALVIN DENTAL SPECIALTIES FIXATION SCREW
Manufacturer
SALVIN DENTAL SPECIALTIES, INC.
Date Cleared
2010-05-10
(109 days)
Product Code
DZL
Regulation Number
872.4880Why did this record match?
Applicant Name (Manufacturer) :
SALVIN DENTAL SPECIALTIES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Salvin Bone Tack System is designed to stabilize a barrier membrane onto a region of cortical plate. This may be used in craniofacial, maxillofacial, or mandibular bone. Considerations such as quality of bone, bone type, functional loads exerted, general patient health and others should be carefully evaluated prior to use.
Device Description
The Salvin Bone Tack System consists of 3mm and 5mm Titanium (Ti-6Al-4V) bone tacks and associated instrumentation. The devices are provided non-sterile.
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K Number
K073342Device Name
SALVIN DENTAL SPECIALTIES, INC., FIXATION SCREW
Manufacturer
SALVIN DENTAL SPECIALTIES, INC.
Date Cleared
2008-03-26
(119 days)
Product Code
DZL
Regulation Number
872.4880Why did this record match?
Applicant Name (Manufacturer) :
SALVIN DENTAL SPECIALTIES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended for use in internal fixation of small bones including the craniofacial and maxillofacial skeleton affected by trauma, or for reconstruction. Single patient use only
Device Description
The Salvin Dental Specialties Titanium Fixation Screw System consists of 1.5mm and 2.0mm Titanium (Ti-6Al-4V) bone screws in lengths of 4, 6, 8, 10, 13 and 15mm. The 2.0mm diameter screws are “emergency” screws. The devices are provided non-sterile.
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