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510(k) Data Aggregation
K Number
K212775Device Name
Adin Short Implants
Manufacturer
Adin Dental Implants Systems Ltd.
Date Cleared
2022-07-08
(310 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Adin Dental Implants Systems Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Adin Dental Implants are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in fully or partially edentulous patients in order to restore a patient's chewing function. Adin Dental Implants may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading. Adin short implants are to be used only with straight abutments.
Device Description
Adin Short Implants are self-tapping root-form two-piece screw type dental implants, indicated for use in Surgical and restorative applications for placement in the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Adin's Short Implants are provided in 6.25mm length and 4.2mm, 5.0 mm, and 6.0mm diameters. As two-piece devices, like the predicate devices, Adin Short Implants are to be used in combination with cover screws, healing caps and straight abutments. The Adin Short Implants are made of Titanium 6AL-4V-ELI Alloy, complying with ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.
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K Number
K153111Device Name
TOUAREG CloseFit UNP 2.75mmD
Manufacturer
Adin Dental Implants Systems Ltd.
Date Cleared
2016-05-06
(191 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Adin Dental Implants Systems Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TOUAREG CloseFit™ UNP 2.75mmD implants are indicated to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla. For single-stage or two-stage procedures. For immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When an one-stage surgical is applied, the implant maybe immediately loaded when good primary stability is achieved and thefunctional load is appropriate.
The TOUAREG CloseFit™ UNP 2.75mmDDental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors.
Device Description
The TOUAREG CloseFit™ UNP 2.75mmD spiral implant system is comprised of a tapered core implant with a spiral tap, with unique tip and triple lead thread design (3x1mm).
The TOUAREG CloseFit™ UNP 2.75mmD spiral implant system offers a unique, strong and solid conical-hex connection.
All Touareg CloseFit™ implants feature the OsseoFix™ surface treatment The TOUAREG CloseFit™ UNP 2.75mmD implant is provided with a diameter of 2.75mm and lengths of 10, 11, 13, 16 and 18 mm.
The TOUAREG CloseFit™ UNP 2.75mmD implants are two piece devices whereas the implant is to be used in combination with cover screws, healing abutments and abutments.
The TOUAREG CloseFit™ UNP 2.75mmD implants, abutments, and abutment fixation screw are made of Ti6AL4V ELI complying with standard ASTM F 136-08- Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant.
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K Number
K140293Device Name
TOUAREG NP CLOSEFIT DENTAL IMPLANTS SYSTEM
Manufacturer
ADIN DENTAL IMPLANTS SYSTEMS LTD.
Date Cleared
2014-10-31
(268 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
ADIN DENTAL IMPLANTS SYSTEMS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended use for Touareg NP CloseFit™ Dental Implant System:
- To replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla.
- For single-stage or two-stage procedures.
- For immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant maybe immediately loaded when good primary stability is achieved and the functional load is appropriate.
- The Touareg NP CloseFit™ Dental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors.
- The Trans Mucosal Abutment (TMA) is indicated for multiple-unit, screw-retained restorations, and may be used in combination with an implant level framework design.
Device Description
Adin Touareg NP CloseFit™ dental implants are intended to be used as a replacement for missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla.
Touareg NP (Narrow-Platform) CloseFit™ Dental Implants consists of root form dental implants of various lengths and diameters and associated abutment systems, which provide the clinician with cement retained, screw retained and overdenture-type restorative options.
Dental implants are surgically inserted into the upper and are left to heal (osseointegrate) with the bone for a period of up to six months. Upon healing and integration with the bone, the cover screw or healing abutment (if used) is removed, impressions are taken, and either a transmucosal abutment (which will later be attached to a custom prosthesis) or a healing abutment is attached to the implant. The soft tissues are allowed to heal around the abutment forming the soft tissues to the contours of the abutment "emergence" profiling. The implant becomes the artificial root structure for a prosthetic tooth or as an abutment structure for bridge work and/or denture retention. Touare TM-NP Dental Implants are available in diameter of 3.0mm with lengths of 8.10. 11.5, 13, and 16 mm. The implants and abutments are made from Ti-Al-V alloy which meets ASTM F-136 (Standard Specification for Wrought Titanium 6Al-4V ELI Allov for Surgical Implant Applications).
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