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510(k) Data Aggregation
K Number
K233419Device Name
GBR System
Manufacturer
Proimtech Saglik Urunleri Anonim Sirketi
Date Cleared
2025-01-03
(451 days)
Product Code
DZL
Regulation Number
872.4880Why did this record match?
Applicant Name (Manufacturer) :
Proimtech Saglik Urunleri Anonim Sirketi
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Guided Bone Regeneration (GBR) System is used to stabilize and fix bone filling materials and/or barrier membranes used for bone regeneration in the oral cavity.
Device Description
The Guided Bone Regeneration (GBR) System is used to stabilize and fix bone filling materials and/or barrier membranes used for bone regeneration in the oral cavity.
MATERIALS: Only materials approved for medical purposes are used in the manufacture of products: Pure Titanium Grade 4 according to standard ISO 5832-2 and ASTM F67-13.
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K Number
K231502Device Name
Mini Screws
Manufacturer
Proimtech Saglik Urunleri Anonim Sirketi
Date Cleared
2024-09-04
(469 days)
Product Code
OAT
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Proimtech Saglik Urunleri Anonim Sirketi
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Orthodontic Screw is indicated for use as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only. The orthodontic screw is intended in patients aged 12 years and older.
Device Description
The Mini Screws system has been designed to provide a firm anchorage point in the oral cavity for orthodontic treatment. Mini screws are manufactured with CP Ti Gr 4 and are SLA treated. The Mini Screw system is designed to be applied with different orthodontic solutions and is versatile enough to satisfy different clinical cases. Titanium orthodontic mini screws are intended to provide fixed anchorage for orthodontic treatment used by implanting in the maxillary and mandibular bone. These mini screws used for anchoring purposes can be divided into 3 parts as head, neck and body.
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K Number
K231100Device Name
Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw
Manufacturer
Proimtech Saglik Urunleri Anonim Sirketi
Date Cleared
2024-08-23
(493 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Proimtech Saglik Urunleri Anonim Sirketi
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indications for use Bilimplant® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.
Bilimplant Abutments and Prosthetic parts are intended for use with Implants in the maxillary and / or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients.
Device Description
The Bilimplant® dental implants and abutments, which are models within the Proimtech Implant and Abutment system, are intended for oral implantation to provide a support structure for connected prosthetic devices.
Bone Level Implant: Thanks to its design features, it is placed completely at the bone level. It is produced to be applied in different bone types and different regions (anterior and posterior) in the lower and upper jaw. Since it is at the bone level, it can be used for more aesthetic results, especially in the front areas of the jaws (in the areas on the smile line).
Tissue Level Implant: The Tissue Level Implant has a 2.3 mm machined collar. It can be used in posterior applications in the upper and lower jaw where there are no aesthetic concerns, in different bone types and especially in cases with high gingival amount in order to facilitate prosthetic stages.
Straight Abutments: It is the superstructure part that supports fixed partial dentures manufacture on a straight implant. It is used in single member or bridge cemented restorations. Cement retained abutments have a different gingival height of 1-5 mm, diameters of 3.5, 4.5, 6 mm depending on the platform diameters.
Healing Caps: Following the second surgery of the gingiva in two-stage surgical procedures, and after the placement of the implant in single-stage surgeries, it is screwed into the implant body and protects the internal structure of the implant. It is not used to support a prosthetic superstructure. It is used for transgingival healing and shaping of soft tissue during the healing process of soft tissue. There are two different designs for healing caps in dental implant systems. These are manufactured to be compatible with tissue level and bone level implants.
Abutment Screws: Connects and fixes the abutment and implant body.
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