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Pro Zygoma dental implants are intended for placement in the maxillary arch to provide support for fixed or removable dental prostheses in patients with partially or fully edentulous maxillae. The Pro Zygoma dental implants may be used with single-stage or two-stage procedures and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

The purpose of this submission is to seek initial clearance for S.I.N. Tapered Pro Conical Zygoma Implant System which includes various endosseous dental implants and corresponding prosthetic components. S.I.N. Tapered Pro Conical Zygoma Implant System adds to the S.I.N. Dental Implant System, which includes several components previously cleared in K231127 and K240609, as well as other features of the Tapered Pro Conical Implant System previously cleared in K240187. This submission includes Pro Zygoma dental implants for placement in the maxillary arch, with corresponding Pro Conical Multi-unit Abutments with up to 60° angulation.

The subject Pro Zygoma dental implants have an internal conical abutment connection, with a 15° cone taper. The Pro Zygoma dental implants are provided with body/platform diameters of 3.8 and 4.2 mm, and each body/platform size is provided in overall lengths of 30, 32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 55, 57.5 and 60 mm. For all implants, the threads start at the apex and extend 16.8mm coronally.

The external machined surface of the subject Pro Zygoma implants, as well as the external surface of the Pro Conical Angled multi-unit abutments are colored yellow for aesthetic and identification purposes by a standard anodization process in which the devices are submerged in an electrolytic solution and exposed to an electric current to increase the thickness of the natural oxide layer on the surface and impart a distinctive color. No dyes are used in this process. The multi-unit abutment screw (part number SCMUAS) is anodized blue by the same process. The anodization process for the subject Pro Zygoma implants is identical to that used on the reference implant devices cleared in K240187. The anodization process for the subject Pro Conical Angled multi-unit abutments and multi-unit abutment screw is identical to that used on the primary predicate abutment devices cleared in K231127.

Resorbable Blast Texturing (RBT) is applied to the threaded surface of all subject device implants creating a random, roughened texture which increases the implant surface area and helps achieve hard tissue (bone) attachment with the implant. RBT is the application, under pressure, of biocompatible hydroxylapatite (HA) particles (conforming to ASTM F1185 Standard Specification for Composition of Hydroxylapatite for Surgical Implants) to the exterior of the machined implant threads. Not to be confused with HA coating, RBT processing uses HA particles to blast the implant surface without depositing HA onto the surface. The HA used for RBT processing does not remain on the surface post-processing. HA media grain size is between 180 – 300 µm for the surface trademarked as RBT (surface finish at 60 Ra minimum).

The subject Pro Conical Angled abutments are multi-unit, indexed abutments for use only with the subject Pro Zygoma implants. The 45°, 52° and 60° Pro Conical Angled Multi-unit Abutments have a prosthetic platform diameter of 4.8 mm, and a gingival height ranging from 1.5 mm to 3.0 mm and are designed only for use with the Pro Zygoma implants. The internal conical implant-abutment connection of the subject devices is identical to that of the BioHorizons reference devices included in K240187, thus the subject Pro Zygoma dental implants are fully compatible with the BioHorizons Conical Multi-unit Angled Abutments (17° and 30°).

All subject dental implants are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136. All subject implants have a resorbable blast textured (RBT) surface treatment, identical to that cleared in K240187. All subject multi-unit abutments are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136. All subject implants and abutments are provided sterile to the end user.

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The LOCATOR Angled Abutment is indicated for the attachment of full or partial, fixed and removable restorations retained by endosseous implants to restore masticatory function for the patient.

The purpose of this submission is to expand the indications of the LOCATOR® Angled Abutment product line to include use with new dental implant systems. This was achieved through collaboration with the implant manufacturers BioHorizons and Implant Direct to prove compatibility of the design of the implant to abutment connection, and equivalence of design specification and performance characteristics.

Previously, the LOCATOR Angled Abutment has been cleared by FDA in applications K233587, K243272, and K250721 for use with various dental implant systems by the manufacturers BioHorizons, Implant Direct, Implant Logistics, Neodent, Nobel Biocare, Straumann, and ZimVie (Zimmer). These LOCATOR Angled Abutments are also designed and cleared for use with removable LOCATOR® Attachment Systems (K072878) and LOCATOR FIXED® (K213391), intended for the attachment of full or partial, fixed and removable, restorations retained by endosseous implants in the mandible or maxilla. This 510(k) submission expands the indications of the LOCATOR Angled Abutment product line with new connections compatible with the following implant systems from BioHorizons (Camlog) and Implant Direct.

• BioHorizons Tapered 3.0 (Internal Hex)
• BioHorizons Tapered Pro Conical Narrow platform (CONELOG)
• BioHorizons Tapered Pro Conical Regular platform (CONELOG)
• BioHorizons Tapered Short Conical Regular platform (CONELOG)
• Implant Direct Legacy 3, 3.0mmD

Compatibility of the new LOCATOR Angled Abutments and screws with either the BioHorizons or Implant Direct implants has been demonstrated through documented collaboration with the OEM. This was achieved by utilizing the OEM's design specifications, which were shared with Zest to create a LOCATOR Angled Abutment and screw that is equivalent to the implant manufacturer's own abutment device in how it interfaces with their respective implant system(s). Additionally, the LOCATOR Angled Abutment parameters deemed critical to ISO 14801 fatigue testing are also equivalent to the manufacturer's cleared abutment specifications, and therefore do not create a new worst case construct or condition. An equivalent specification is deemed as being identical to or within the OEM's defined specification.

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