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K Number
K152576Device Name
Anker II Dental Implant System
Manufacturer
Alliance Global Technology Co., Ltd.
Date Cleared
2016-06-02
(267 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Alliance Global Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Anker II Dental Implant System is intended to be surgically placed in the alveolar bone of upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.
Anker II Dental Implant System is intended for delayed loading. No matter placing implants in anterior or posterior region, we recommend choosing the diameter of implants as large as possible. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments).
Specific indications for small diameter (≥03.3mm) and short (length ≤ 7mm) dental implants: Because of their reduced mechanical stability, small diameter and short implants are only used in cases with a low mechanical load. We recommend only used in the maxillary lateral incisor or the mandibular central incisors.
Device Description
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K Number
K142557Device Name
Anker Dental Implant System - SB-III, ST and AT series
Manufacturer
Alliance Global Technology Co., Ltd.
Date Cleared
2015-09-21
(375 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Alliance Global Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Anker Dental Implant System is intended to be surgically placed in the alveolar bone of upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.
Anker Dental Implant System is intended for delayed loading. No matter placing implants in anterior or posterior region, we recommend choosing the diameter of implants as large as possible. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments).
Specific indications for small diameter (Ø 3.3mm) and short (length < 7mm) dental implants:
Because of their reduced mechanical stability, small diameter and short implants are only used in cases with a low mechanical load. We recommend only used in the mandibular anterior region and maxillary lateral incisor.
Device Description
Anker Dental Implant System is an integrated system which includes Bone Level (SB-III series) and Tissue Level (ST and AT series) dental implants.
Anker Dental Implant System SB-III series consists of fixture, abutments (healing abutment, fixed abutment, dual abutment, angle abutment, o-ring abutment, temporary abutment, convertible abutment, convertible protect cap, convertible combination cylinder, convertible angled cylinder, convertible temporary cylinder, angled screw abutment, temporary cylinder) and cover screw.
Anker Dental Implant System ST and AT series consist of fixture, abutments (healing cap, solid abutment, cementable abutment, angled abutment, temporary restoration screw, screw retained abutment, locator abutment) and closure screw.
Fixtures are made of pure titanium (grade IV) and there surface was treated by SLA (Sand-blasted, Large grit. Acid-etched) process. Diameters of fixtures are including 3.3 to 5.0 mm and lengthes are including 7.0 to 15.0 mm. Cover screw, closure screw and most abutments are made of titanium alloy. Temporary abutment and convertible temporary cylinder (SB-III series) are made of SUS316L stainless steel instead of titanium alloy. All products are sterilized as finished products.
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