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510(k) Data Aggregation
K Number
K210489Device Name
SICtapered & SICvantage tapered
Manufacturer
SIC invent AG
Date Cleared
2022-03-17
(391 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
SIC invent AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SICtapered Implants are intended for use during dental implantation and oromaxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or bridges which restore the patient's chewing function. SICtapered Implants are indicated for when adequate primary stability is achieved and with appropriate occlusal loading. Only applicable for SICtapered implants with Ø 3.7 mm Use without splinting is permissible in the anterior and premolar region, they must be used in rigid combination with other implants. In all cases, they may only be where loads are not extreme. SICvantage tapered Implants are intended for use during dental implantation and oro-maxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or bridges which restore the patient's chewing function. SICvantage tapered Implants are indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading. Only applicable for SICvantage tapered implants with Ø 3.0 mm Use without splinting is permissible in the anterior replacement of maxillary lateral incisors and mandbular incisors. In the premolar and molar region, they must be used in rigid combination with other implants. In all cases, they may only be where loads are not extreme.
Device Description
The SICtapered is a two-part, self-tapping, endosteal threaded implant. The basic shape is conical with an initially tapered "apical cutting edge". The cortical area is cylindrical, and the core diameter is increased. On the top of the implant, there is a decompression zone to reduce the compression on the bone and a crestal bevel designed for "platform switching". The apex has an aggressive cut with a large flute for good chip clearance. The vertical fixation screw is secured with a torque of 20 Ncm. The implants are manufactured from medical-grade pure titanium (ISO 5832-2). The microstructuring of the surface is achieved by abrasive processes. Surgical accessories and prosthetic abutments are usually color-coded by means of anodized oxidation. The SICvantage tapered is a two-part, self-tapping, endosteal threaded implant. The basic shape is conical with an initially tapered "apical cutting edge". The cortical area is cylindrical, and the core diameter is increased. On the top of the implant, there is a decompression zone to reduce the compression on the bone and a crestal bevel designed for "platform switching". The apex has an aggressive cut with a large flute for good chip clearance. The SICvantage tapered can be used in all bone qualities (D1 – D4). The implants are manufactured from medical-grade pure titanium (ISO 5832-2). The microstructuring of the surface is achieved by abrasive processes. Surgical accessories and prosthetic abutments are usually color-coded by means of anodized oxidation.
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K Number
K173207Device Name
SIC invent Dental Implant Systems
Manufacturer
SIC invent AG
Date Cleared
2018-04-05
(185 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
SIC invent AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SICmax onepiece implants are intended for use during dental implantation and oromaxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or bridges which restore the patient's chewing function. SICmax onepiece Implants are indicated for replacing maxillary lateral incisors and mandibular central and lateral incisors. Splinting with several implants or the residual dentition is possible. SICmax onepiece implants are also indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading.
SICace Implants are intended for use during dental implantation and oromaxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or bridges which restore the patient's chewing function. SICace Implants are indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading.
- Only applicable for SICace implants with Ø 3.4 mm: Use without splinting is permissible in the anterior and premolar region. In the molar region, they must be used in rigid combination with other implants. In all cases, they may only be where loads are not extreme.
SICmax Implants are intended for use during dental implantation and oromaxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or the patient's chewing function. SICmax Implants are indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading.
- Only applicable for SICmax implants with Ø 3.7 mm: Use without splinting is permissible in the anterior and premolar region. In the molar region, they must be used in rigid combination with other implants. In all cases, they may only be where loads are not extreme.
SIC vantage max Implants are intended for use during dental implantation and oromaxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or bridges which restore the patient's chewing function. SICyantage max Implants are indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading.
- Only applicable for SIC vantage max implants with Ø 3.0 mm: Use without splinting is permissible in the anterior region for replacement of maxillary lateral incisors and mandibular incisors. In the premolar and molar region, they must be used in rigid combination with other implants. In all cases, they may only be where loads are not extreme.
SIC Prosthetic Components are intended for use with SIC Dental Implants for prosthetic restorations from single tooth replacements to full arch restorations with fixed or removable superstructures. SIC Prosthetic Components with a post height less than 4 mm are intended for multi-unit loaded restorations only.
Device Description
SICmax onepiece implants are intended for use during dental implantation and oromaxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or bridges which restore the patient's chewing function. SICmax onepiece Implants are indicated for replacing maxillary lateral incisors and mandibular central and lateral incisors. Splinting with several implants or the residual dentition is possible. SICmax onepiece implants are also indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading.
SICace Implants are intended for use during dental implantation and oromaxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or bridges which restore the patient's chewing function. SICace Implants are indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading.
- Only applicable for SICace implants with Ø 3.4 mm: Use without splinting is permissible in the anterior and premolar region. In the molar region, they must be used in rigid combination with other implants. In all cases, they may only be where loads are not extreme.
SICmax Implants are intended for use during dental implantation and oromaxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or the patient's chewing function. SICmax Implants are indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading.
- Only applicable for SICmax implants with Ø 3.7 mm: Use without splinting is permissible in the anterior and premolar region. In the molar region, they must be used in rigid combination with other implants. In all cases, they may only be where loads are not extreme.
SIC vantage max Implants are intended for use during dental implantation and oromaxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or bridges which restore the patient's chewing function. SICyantage max Implants are indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading.
- Only applicable for SIC vantage max implants with Ø 3.0 mm: Use without splinting is permissible in the anterior region for replacement of maxillary lateral incisors and mandibular incisors. In the premolar and molar region, they must be used in rigid combination with other implants. In all cases, they may only be where loads are not extreme.
SIC Prosthetic Components are intended for use with SIC Dental Implants for prosthetic restorations from single tooth replacements to full arch restorations with fixed or removable superstructures. SIC Prosthetic Components with a post height less than 4 mm are intended for multi-unit loaded restorations only.
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K Number
K061500Device Name
SICACE DENTAL IMPLANT SYSTEM AND SIC ANGLED ABUTMENTS
Manufacturer
SIC INVENT AG
Date Cleared
2006-08-08
(69 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
SIC INVENT AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SICace System Dental Implant is a root form endosseous dental implant system that is indicated to be implanted in the upper and/or lower jaw arches. The implants may be used in combination with various SICace System Abutments for single or multiple unit prosthetic attachment to restore a patient's chewing function.
Patient's must be applicable for dental treatment with endosseous implants.
In cases where the ridge is too narrow to receive a 4.0 mm or a 5.0 mm diameter implant, the 3.4 mm implant can be used. Because of reduced strength due to the small diameter, these implants should be rigidly joined to other implants and used only where loads are not extreme.
The SICace System Abutment is intended to be placed into the SICace System Implant to provide a safe and effective fit of screw retained and/or cementable crowns and bridges.
Device Description
SICace dental implant system is a root-form endosseous dental implant device made out of grade 4 titanium according ASTM F 67. The implants are available in three different diameters (ø3.4 mm, ø4.0 mm, ø5.0 mm) and various lengths from 9.5 mm. The anchorage surface is grit blasted and acid etched for faster osseointegration and secondary stability.
Equal to the predicate device SICpro dental implant, the face side of the SICace dental implant has a hexagon drill hole and a standard screw thread to ensure and anti-rotational connection of the congruent abutment and the implant. Throughout the different diameters the hexagon drill hole has identical measurements.
SICace dental implants are delivered single packed in combination with an implant cover screw and supplied in sterile condition (sterilized by gamma-radiation).
SIC angled abutments are various in lengths and diameters and made out of titanium ASTM F 136. Through a hexagon socket and a vertical drill hole, the abutments can be connected with the implant secure and anti-rotational.
SIC angled abutments are supplied in non sterile condition. These parts of the system can be sterilized by the user by using a standardized and validated sterilization process.
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K Number
K040757Device Name
SIC PRO
Manufacturer
SIC INVENT AG
Date Cleared
2005-04-13
(384 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
SIC INVENT AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SIC pro System Dental Implant is a root form endosseous dental implant system that is indicated to be implanted in the upper and/or lower jaw arches. The implants may be used in combination with various SIC pro System Abutments for single or multiple unit prosthetic attachment to restore a patient's chewing function.
Patient's must be applicable for dental treatment with endosseous implants. In cases where the ridge is too narrow to recieve a 4.2mm or 5.3mm diameter implant, the 3.3mm implant can be used. Under such conditions, we highly recommend the placement of additional fixtures to share the occlusal load of the prosthetic restoration. The SIC pro System Abutment is intended to be placed into the SIC pro System Implant to provide a safe and effective fit of screw retained and/or cementable crowns and bridges.
Device Description
SIC pro System solid screw dental implants are root-form endosseous dental implant devices ono of of grade 4 titanium according ASTM F 67. The implants are available in three different diameters (ø3.3 mm, ø4.2 mm, ø5.3 mm) and various length from 7.5 mm up to 16 mm. All ø3.3 mm diameter implants are cylindrical as well as the implants in diameter ø4.2 mm and ø5.3 mm in length of 7.5mm. All other implants in diameter ø4.2 mm and ø5.3 mm are partly tapered. The rength of 7.3mm. All other implants in acid etched for faster osseointegration and secondary stability.
The face side of the implant has a hexagon drill hole and a standard screw thread to ensure a The face side of the implant not a noxagon and the implant. Throughout the implant. Throughout the different diameters the hexagon drill hole has identical measurements.
SIC pro System Implants are delivered single packed in combination with a implant cover screw and supplied in sterile condition (sterilized by gamma-radiation).
SIC pro System Abutments & Accessories are various in shape, length and diameters and made out of three different materials (titanium grade 5, implant steel 316L, zirconium oxide). Through a hexagon socket and a vertical drill hole, the abutments can be connected with the implant secure and anti-rotational.
SIC pro System Abutments & Accessories are supplied single packed in non-sterile condition. These parts of the system are intended to be sterilized by the user by and have been validated by These parts of the system are intoneed steam (autoclave) sterilization process (15 min., 136°C, 3 bar).
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