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NobelActive® S TiUltra™, NobelActive® S TiUnite®

NobelActive® S TiUltra™ and NobelActive® S TiUnite® implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function.

NobelActive® S TiUltra™ and NobelActive® S TiUnite® implants are indicated for single or multiple unit restorations in splinted or non-splinted applications.

This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.

NobelReplace® S TiUltra™, NobelReplace® S TiUnite®

NobelReplace® S TiUltra™ and NobelReplace® S TiUnite® implants are endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function.

The NobelReplace® S TiUltra™ and NobelReplace® S TiUnite® implants are indicated for single or multiple unit restorations.

The NobelReplace® S TiUltra™ and NobelReplace® S TiUnite® implants can be used in splinted or non-splinted applications.

The NobelReplace® S TiUltra™ and NobelReplace® S TiUnite® implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

NobelParallel™ S TiUltra™, NobelParallel™ S TiUnite®

NobelParallel™ S TiUltra™ and NobelParallel™ S TiUnite® implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting replacements to restore patient esthetics and chewing function.

NobelParallel™ S TiUltra™ and NobelParallel™ S TiUnite® implants are indicated for single or multiple restorations in splinted or non-splinted applications.

This can be achieved by 2-stage or 1-stage surgical techniques in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.

Implants with <7 mm length are for delayed loading only when appropriate stability has been achieved.

The Subject Device, Nobel Biocare S Series Implants, comprises of six Device Lines NobelActive S TiUltra™, NobelParallel™ S TiUltra™, NobelReplace S TiUltra™, NobelActive S TiUnite, NobelParallel™ S TiUnite, NobelReplace S TiUnite.

Nobel Biocare S Series Implants are intended for use as an endosseous dental implant in the maxilla or mandible for anchoring or supporting dental prostheses to restore chewing function. The Subject Device features a consistent diameter at the implant-abutment interface, regardless of the implant size or type. This means that the prosthetic components, such as abutments and restorative elements, have uniform dimensions and connections across all implant sizes within the system. The connection used is the Narrow Platform (NP) conical connection.

The implant bodies of the Subject Devices and Predicate devices are the same. This allows use of the same drills and drilling protocols, rescue procedures and rescue tools. By using the existing Narrow Platform connection, the same prosthetic workflows, prosthetic components, and lab components can be used.

The implants are available in different sizes as listed in Table 1.

The Nobel Biocare S Series Implants are manufactured from commercially pure titanium and incorporate a conical connection (Size Narrow Platform (NP)) with a hex interface in the collar region, which combines with Nobel Biocare's existing prosthetic Abutment portfolio cleared in K071370, K083100, K132746, K233208, K202344, K200040, K132749, K161416, K202452, K240346, K041236, K133731, K061003 and K161435.

Table 2 outlines which single-unit restoration abutments with an NP connection can be used with the subject device.

Table 3 outlines which multi-unit restoration abutments and bridges with an NP connection can be used with the subject devices.

Table 4 outlines the temporary and healing restorations with an NP connection that can be used with the subject devices.

Table 5 lists the corresponding submissions where compatible Class II accessories with an NP connection were previously identified.

The On1™ Base/On1™ Base Xeal must not be used in combination with NobelActive® S, NobelParallel™ S, NobelReplace® S implants.

NobelActive® S, NobelParallel™ S, NobelReplace® S implants in combination with NobelProcera® Angulated Screw Channel Abutment and NobelProcera® FCZ Implant Crown are indicated for maxillary lateral and mandibular central/lateral incisors only.

NobelActive® S, NobelParallel™ S, NobelReplace® S implants may be used in combination with NobelProcera® Angulated Screw Channel Abutment and NobelProcera® FCZ Implant Crown up to a maximum angulation of 20°

NobelActive® S, NobelParallel™ S, NobelReplace® S implants may be used in combination with GoldAdapt Engaging CC NP abutments in straight (0°) configurations only.

No angulation is allowed for Universal Base Conical Connection Abutments when mated with the NobelActive® S, NobelParallel™ S, NobelReplace® S implants with diameters greater than 3.5mm.

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The TiArray Dental Implant System is intended to be surgically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

TiArray Dental Implant System implants included in this submission are endosseous dental implants with an internal hex implant/abutment interface. They are designed to provide support for prosthetic teeth to restore chewing function. The implants are made of commercially pure titanium, with a surface that is etched and anodized. Implants are provided in a tapered, threaded design with micro-grooves around the neck of the implant and two cutting flutes. Straight abutments made of titanium alloy are provided for each diameter implant for cement-retained prostheses. The implant is available in three diameters (3.5, 4.3, and 5.0 mm), each in four lengths (8.0, 10.0, 11.5, and 13.0). The abutments come in three platform diameters (3.5, 4.3, and 5.0 mm) that correspond to the diameters of the implant.

The provided text does not contain information about acceptance criteria or a study demonstrating that the device meets such criteria.

The 510(k) summary for the TiArray Dental Implant System (K131345) states:

• "Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility, engineering analysis and dimensional analysis."
• "Clinical data were not submitted in this premarket notification."

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and type of ground truth cannot be extracted from this document. The submission relies on non-clinical data to demonstrate substantial equivalence to predicate devices, rather than a study against specific acceptance criteria.

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