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510(k) Data Aggregation
K Number
K192053Device Name
W Zirconia Implants
Manufacturer
TAV Medical Ltd.
Date Cleared
2019-10-29
(90 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
TAV Medical Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TAV Medical's W Zirconia Implants are intended for surgical placement in the patient's upper and lower jaw to provide support for prosthetic devices, such as artificial teeth and in order to restore the patient chewing function. The implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. The ø3.6mm reduced diameter implants are recommended for central and lateral incisors only.
Device Description
TAV Medical's W Zirconia Implants are dental implants, composed of the following implant models: W One Piece - monotype implant with integrated abutment. W Two Piece – implant for screw retained Abutment. The implants are tissue level designed and includes a body portion and a neck (1.8mm). The implant body portion is configured to extend into the bone and osseo-integrate with the alveolar bone. The neck should be positioned 1.8mm above the bone level. TAV Medical's W Zirconia Implants are made of Yttria stabilized tetragonal zirconia (Y-TZP). This material conforms with ISO 13356:2015 standard for Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP). The Titanium abutments are going through anodizing process using an electrolytic process that adjusts the oxide level of the metal surface. This adjustment changes the spectrum of light, resulting in perceived color. By controlling the surface oxide level, an entire range of colors can be achieved. The Subject Device includes the following dimensions: W One-Piece implants: Diameter of 3.6mm for lengths of 8mm, 10mm, 12mm and 14mm and; Diameters of 4.1mm and 4.8mm for length of 14mm. W Two-Piece implants: Diameters of 4.1mm and 4.8mm for lengths of 8mm, 10mm, 12mm and 14mm. Cover Screw are screwed into the implant to protect the inner configuration of the implant during the healing phase in cases of submucosal healing protocol. Cover screws are made of Titanium alloy Ti 6Al 4V ELI & Anodize and are available in diameters of 4.1mm and 4.8mm. Titanium Healing Caps are intended to protect the 2-piece implants during the healing phase. The healing caps also support the emergence profile and keep the implant shoulder ideal for the impression phase. The healing caps are available in different geometrical features such as height and diameter. The Titanium Healing Caps manufactured from Ti 6Al 4V ELI & Anodize and are available in diameters of 4.1mm and 4.8mm. Each diameter is provided with height dimensions of 1mm, 2mm, 3mm and 4mm. PEEK Healing Caps are designed to protect the two-piece implant during the healing phase. The healing caps also support the emergence profile and keep the implant shoulder ideal for the impression phase. Peek healing caps are available in different geometrical features such as height and diameter and available in 2 different designs, one design for the one-piece implant and second design for the two-piece implant. Both designs are manufactured from PEEK material and are indicated to be placed in patients' mouth for a maximum duration of 180 days. The PEEK healing caps are available in diameters of 4.1mm and 4.8mm and height dimensions of 1mm, 2mm, 3mm and 4mm. PEEK Temporary Caps serves as a basis for temporary restoration. TAV Medical temporary restoration caps available in two configurations, temporary Cap for Crown and Temporary Cap for Bridge. The caps are manufactured from PEEK material and are indicated to be placed in patients' mouth for a maximum duration of 180 days. The PEEK temporary caps are available in diameter of 3.6mm. Titanium Abutments for the W Two Piece Zirconia Implants are intended for use as an adapter between the implant and the crown. The abutments are characterized by distinct geometrical features such as length and angulation. The titanium abutments are manufactured from ASTM F136-13 compatible Titanium Ti 6Al 4V ELI & Anodize. TAV Medical abutments are intended to be connected to 2-piece W Zirconia implants with titanium screw, to provide support for prosthetic reconstructions. The abutments are available in the following dimensions: Length of 5.0mm and 6.0mm and Angles of 0°, 5°, 10° and 15°. The 0º serves also for bridges.
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K Number
K172668Device Name
W Zirconia Implants
Manufacturer
TAV Medical Ltd.
Date Cleared
2018-11-06
(427 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
TAV Medical Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TAV Medical's W Zirconia Implants are intended for surgical placement in the patient's upper and lower jaw to provide support for prosthetic devices, such as artificial teeth and in order to restore the patient chewing function. The implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Device Description
W Zirconia Implants are suitable for one or two stage endosseous form of dental implants. One Piece and Two-Piece implants are available. The abutments are used in conjunction with the endosseous dental implant in order to support in the prosthetic rehabilitation. The implantation procedure can be accomplished, for the One-piece implant in a one stage and for the two piece implant in a one or two stage surgical procedures. TAV Medical's W Zirconia Implants are composed of the following implant models: W One Piece – monotype implant with integrated abutment. W Two Piece –implant for screw retained Abutment. In both implants the endosteal region is provided with a roughness with a Ra value of 2.3 µm. The implants and abutments are tissue level designed and includes a body portion (implant body diameter 4.1 mm with a 4.8 mm platform, and implant body diameter 4.8 mm with a 6.0 mm platform) and a neck (1.8mm). The implant body portion is configured to extend into the bone and osseo-integrate with the alveolar bone. The neck should be positioned 1.8mm above the bone level. TAV Medical's W Zirconia Implants are made of Yttria stabilized tetragonal zirconia (Y-TZP). Each Two piece implant is accompanied with a standard titanium cover screw.
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K Number
K170131Device Name
TAV Medical Dental Implants System
Manufacturer
Tav Medical Ltd.
Date Cleared
2018-02-10
(389 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Tav Medical Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TAV Medical Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth and in order to restore the patient chewing function. The Implants are indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Device Description
TAV Medical Dental Implant System is a two piece dental implant system for one stage or two stage surgical implantation of dental implant provided with cover screw and supported by a compatible abutment systems and surgical instruments. The implant is fabricated from a medical grade titanium alloy 6Al 4V ELI, according to ASTM F136. TAV Medical implant includes a body portion and a collar. The body portion is configured to extend into and Osseo integrate with the alveolar bone. The top surface of the collar lies flush with the crest of the jawbone bone. TAV Medical abutment lies on the top surface and extends through the soft tissue, which lies above the alveolar bone. The abutment supports the final prostheses. TAV Medical implants include the following brands: Silhouette, Sirius, and iCone. TAV Medical Abutments are intended for used as an adapter between the implant and the crown. The abutments are characterized by four distinct geometrically features: Height/length, angle, diameter and internal/external hex lock or conical connection. Anodized Color coding is used for categorical consideration only. TAV Medical abutments, as other available in the market of dental prosthetics are dental components composed either of titanium (Ti 6AL 4V ELI), PEEK and Yttrium Stabilized Zirconia (ZrO2). All the abutments fixation screws are composed of Ti 6AL 4V ELI. The abutments are supplied non-sterile to be sterilized by the physician before use according to the accompanied instruction for use. Abutment device refers to the fixture that is assembled on the implant. The crown is then built on the abutment. The prosthetic parts are divided into 3 main categories: Cemented retained restorations, Screw retained restorations, and Overdenture retained. Various abutment types are available: Titanium Abutments, Temporary Esthetic PEEK Abutments, Ball attachment, Locker overdenture, and Healing caps.
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