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K Number
K182219Device Name
SGS Dental Implants System
Manufacturer
SGS International Ltd
Date Cleared
2019-08-29
(379 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
SGS International Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SGS® Dental Implants System is intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. SGS® Dental Implants System may be immediate loading when good primary stability is achieved and with appropriate occlusal loading. Narrow diameter implants (3.2) are intended for maxillary lateral incisors and mandibular lateral and central incisors.
Device Description
SGS® Dental Implants System is consist of endosseous form dental implants, internal hex implants, tapered design; cover screws, healing caps and abutment systems; Dental Implants:
P7N Narrow Conical Implant, Internal Hex available as follow:
Diameter 3.2 mm Length 8 mm
P1D Conical Groovy Double Connection Implant, Internal hex Conical Connection available as follow:
Diameter 3.5, 3.75, 4.2, 5, 6 mm Length 8, 10, 11.5, 13, 16.
P5D Conical Groovy Double Connection Implant, Internal hex Conical Connection available as follow:
Diameter 3.5, 3.75, 4.2, 4.5, 5, 6 mm Length 8, 10, 11.5, 13, 16.
P7D Conical Groovy Double Connection Implant, Internal hex Conical Connection available as follow:
Diameter 3.5, 3.75, 4.2, 4.5, 5, 6 mm Length 8, 10, 11.5, 13, 16.
Dental Abutments consist of:
Healing Abutments, Anatomic Straight Abutments, Straight Abutments, Straight Abutments Narrow/Wide, PEEK Temporary Abutments for bars, Angular Anatomic Abutments Ti, Angular Abutments Slim/Narrow, Multi-Base Angular Abutment, Anqular Ball Attachment, S-lock Straight/Anqular Abutment, Easy-Fix Angular Abutment, Straight/One-piece angular Multi-unit Abutment, Ball Attachments, Abutment for temporary restoration, Easy Fix Abutments Straight/Angular, Smart Lock abutments Straight/Angular, Flat connection abutments for casting, overdenture attachments. Titanium abutments are CNC machined with no anodized surface.
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K Number
K133362Device Name
SGS DENTAL IMPLANT
Manufacturer
SGS INTERNATIONAL LTD
Date Cleared
2014-11-21
(385 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
SGS INTERNATIONAL LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SGS® Dental Implants System is intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. SGS® Dental Implants System may be immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Two Stage Implants: P1, P7, P7N.
One Stage: P7S, P9S.
One Stage & One-Piece 3.0 mm diameter implants: P7S, P9S are intended for placement at the mandibular central and lateral incisors and maxillary and lateral incisors. Indicated also for denture stabilization using multiple implants.
One stage & One-Piece 2.4 mm diameter implants for temporary use or long term use: P9S permit immediate splint stability and long term fixation of new or existing crown, bridge and prosthesis.
PEEK Temporary Abutments are for 30 days.
Device Description
SGS® Dental Implants System consists of one and two stage endosseous form dental implants, internal hexagonal and one piece implants system;
P1 - Screw Type Groovy Implant- Diameter 3.2, 3.75,4.2, 5, 6 Length 8, 10,11.5,13,16
P7 - Conical Groovy Implant - Diameter 3.2, 3.75,4.2, 4.5, 5, 6 Length 8, 10,11.5,13,16 (13,16 not for 3.2 dmm).
P7N - Narrow Conical Implant - Diameter 3, 3.2 Length 10, 11.5, 13, 16
P7S - Integral Groovy Implant - Diameter 3, 3.2, 3.75, 4.2, 5, 6 Length, 10, 11.5, 13, 16
P9S - Thin Integral Implant - Diameter 2.4. 3. 3.2 Length 10. 11.5. 13. 16
Abutments System is compromised of Healing Abutments, Overdenture ball attachments, Straight Titanium Abutments, Angulated Titanium Abutments 15,25, Anatomic Straight Titanium Abutments, Anatomic Angular Titanium Abutments, Anatomic Straight Zirconium Abutments, Straight PEEK Abutments, Temporary Abutments, Screw Type Abutments, Screw Type Angular Abutments and Attachments for Overdenture; impression copy system & surgical instruments are also provided.
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