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510(k) Data Aggregation
K Number
K173570Device Name
SD Abutment
Manufacturer
Surgident Co., Ltd.
Date Cleared
2019-05-17
(543 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
Surgident Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SD Abutment is intended for use in partially or fully edentulous maxilla, in support of single or multipleunit prosthetic restorations. SD Abutment is for single stage and two stage surgical procedures. This system is intended for delayed loading.
Device Description
SD Abutment made of Ti-6A1-4V ELI alloy (ASTM F136) and/or Pure Titanium Gr4 (ASTM F67) is intended for use as an aid in single or multiple-unit prosthetic restorations. It consists of Healing Abutment, Solid Abutment, Dual Abutment, Dual Long Abutment, Angled Abutment (15° and 25°), Temporary Abutment and Abutment Screws. All abutments are supplied non-sterile and autoclaved by the end user.
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K Number
K170697Device Name
GBR system
Manufacturer
SURGIDENT
Date Cleared
2018-05-24
(443 days)
Product Code
JEY, DZL
Regulation Number
872.4760Why did this record match?
Applicant Name (Manufacturer) :
SURGIDENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended for use in stabilizing and fixating bone grafts, bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity. Single patient use only.
Device Description
The GBR System is comprised of bone screws and bone plates that are used for bone fixation surgery. The bone screws and plates are not reusable. The bone screws are composed of the titanium alloy (ASTM F136) and the bone plates are composed of the pure titanium (ASTM F67 Grade 1). The screws are offered in following range; diameter (0.85, 1.4, 2.0 mm) and length (3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0 mm). Also, the tip of screw has single type; the self-drilling and self-tapping available type and the type that require the pre-drilling (Surgeon's option). The bone plate is offered in 0.1 mm thickness and in length 22 mm x 15 mm, 36 mm x 22 mm and 44 mm x 44 mm. Each device is provided non-sterile. Therefore, this device must be sterilized prior to use. Steam sterilization is recommended.
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