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The Paltop Dental Implant System Internal Hex Standard and Wide Platforms implants (implant diameters 3.75 and above and lengths 8mm and above) as well as Conical Connection implants (implant diameters 3.75 and above and lengths 8mm and above), are 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, in order to restore the patient's chewing function. The Paltop Dental Implant System is indicated also for immediate loading, when good primary stability is achieved and with appropriate occlusal loading.

The Paltop Narrow Implant (Internal Hex and Conical Connections, for implant diameters 3.25 and lengths 10mm and above) is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the interdental spaces are limited by the adjacent teeth and roots, to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Paltop Narrow Implant is indicated also for immediate loading, when good primary stability is achieved and with appropriate occlusal loading.

The purpose of this submission is to add components and update previously cleared to the Paltop Advanced Dental Solutions, Ltd product line of endosseous dental implants, abutments, and prosthetic components. Specifically, this submission seeks marketing clearance for dental implants with body diameters of 3.25 mm, 3.75 mm, 4.2 mm, 5 mm, and 6 mm various compatible abutments, two (2) cover screws, and one (1) additional abutment screw.

The subject device dental implants are self-tapping, threaded, root-form dental implants intended for the functional and aesthetic rehabilitation of the partial or fully edentulous mandible or maxilla. Once osseointegrated, the implants act as an anchor for various fixed or removable prosthetic solutions. All subject device implants are intended to be placed at the bone level (crestal position). All implants with diameters of 4.2 mm and 5.0 mm diameters allow for the option of platform switching.

Advanced, Advanced +, Dynamic, PAI, and PAI TC dental implants have an internal hex connection. Each implant line is provided with a body diameter of 3.25 mm, and interface with the Paltop Narrow Platform (NP) prosthetic components, with an interface diameter of 2.90 mm. Implants with the 3.25 mm body diameter are provided in lengths of 10, 11.5, 13, and 16 mm. Each implant line also is provided with body diameters of 3.75, 4.2, and 5 mm; these implants are provided in lengths of 8, 10, 11.5, 13, and 16 mm and interface with the Paltop Standard Platform (SP) prosthetic components, with an interface diameter of 3.65 mm.

The Advanced +, Dynamic, PAI, and PAI TC dental implant lines also are provided in a body diameter of 6 mm, in lengths of 8, 10, 11.5, 13, and 16 mm. Implants with the 6 mm body diameter interface with the Paltop Wide Platform (WP) prosthetic components, with an interface diameter of 4.4 mm. The Advanced +, Dynamic, PAI, and PAI TC dental implants have an internal threaded section (UNF 1-72) for connection to the corresponding cover screw, healing cap, abutment, or abutment screw.

The subject device conical connection implants (Dynamic Conical MC, and PCA) are provided in body diameters of 3.25, 3.75, 4.2, and 5 mm. Conical implants with the 3.25 mm body diameter are provided in lengths of 10, 11.5, 13, and 16 mm; all other body diameter sizes are provided in lengths of 8, 10, 11.5, 13, and 16 mm. All conical implants have a recessed internal section for abutment indexing, and an internal threaded section for connecting with corresponding compatible healing caps, abutments, and screws. Subject device implants with a conical geometry connect to conical connection prosthetic components. The conical connection prosthetic interface diameter is 2.9 mm.

The subject device conical connection implants (Dynamic Conical MC, and PCA) have a recessed 22° internal conical taper and a section for abutment indexing, as well as a threaded section (M1.6 x 0.35) for connection to the corresponding cover screw, healing cap, abutment, or abutment screw.

All subject device titanium abutments and screws are manufactured from titanium alloy conforming to ASTM F136.

The subject device endosseous dental abutments provide a range of cement-retained and screw-retained prosthetic solutions for dental implant restoration. Subject device abutments include seven (7) compatible implant abutment designs: Healing Caps, Straight Abutments, Angulated Abutments, Multi-Unit Abutment, Temporary Abutments, Snap-On Abutment System (SAS), and Ball Abutments for subject and non-subject device implants of the same families (Advanced, Advanced +, Dynamic, PAI, and PAI TC dental implants) and the conical healing caps are compatible with conical subject and non-subject devices (PCA, Dynamic Conical, Dynamic Conical MC). Abutments are offered in either indexed (engaging) or non-indexed (non- engaging) external connections that are compatible with the subject device implants.

Subject device abutments are compatible with the subject device implants with the internal hex connection, and the conical connection implants (subject device healing cap), as well as previously cleared compatible implants as described in Table 4 Subject Device Component Compatibilities. Subject device abutments are compatible with subject device implants according to their appropriate internal connection and platform. Subject device implants with an internal hex connection and diameter size of 3.25 mm (Advanced, Advanced +, Dynamic, PAI, and PAI TC) are compatible with subject device Narrow Platform (NP) Abutments, as well as abutments cleared in K210117. Subject device implants with an internal hex connection and diameter size of 3.75 mm, 4.2 mm and 5.0 mm (Advanced, Advanced +, Dynamic, PAI, and PAI TC) are compatible with subject device Standard Platform (SP) Abutments, as well as abutments cleared in K232740. The 6.0 mm diameter internal hex implants of all lengths (Advanced +, Dynamic, PAI, and PAI TC) are compatible with subject device Wide Platform (WP) Abutments, as well as abutments cleared in K232740. Subject device implants with a conical connection (Dynamic Conical MC and PCA) are compatible with the subject device conical connection healing cap, as well as conical connection abutments cleared in K220200. The 5.0 mm diameter conical connection implants of all lengths (Dynamic Conical MC and PCA) are compatible with conical connection abutments cleared in K232740.

All subject device titanium abutments and screws are manufactured from titanium alloy conforming to ASTM F136.

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The Osteon Precision Milled Suprastructure is indicated for attachments in the treatment of partially or fully edentulous jaws for the purpose of restoring function. The Osteon Precision Milled Suprastructures are intended for attachment to a minimum of two (2) abutments.

The Osteon Milled Suprastructure is indicated for compatibility with the following abutment systems:

• · Astra Tech Implant System® Multi Base Abutment EV, 4.8mm, max 30°
• · BioHorizons Multi Unit Abutment, 4.8mm, max 30°
  • · CONELOG® Implant System
• · Biomet 3 i Multi Unit Abutments, 4.8mm, max 30°
  • · TSXTM Implants
  • · Tapered Screw-Vent Implant
• · DESS Dental Multi Unit Abutments, 3.4-5.7 mm, 0°
  • · 3i OSSEOTITE®
  • · Astra Tech OsseoSpeed™
  • · Neodent Grand Morse
  • NobelReplace® Trilobe
  • · NobelReplace® Conical
  • · Nobel Brånemark System®
  • · Straumann BLX Implants
• · DESS Dental Multi Unit Abutments. Angled. 3.4-6.5 mm, max 30°
  • · NobelActive® NobelParallel Conical
  • Straumann® Bone Level
  • · Zimmer Screw Vent® and Tapered Screw-Vent®
• · Dentium SuperLine® Abutments, 4.5-5.5 mm, max30°
• · Genesis ACTIVE™ Multi-Unit Abutments, 4.8mm, max 30°
• · Implant Direct GPS® Angled Abutment, 5.0mm, max 30°
• KDG Abutments, 4.8mm, max 30°
• · Keystone Multi Unit Abutment, 4.8mm, 0°
• · Medentika Multi Unit Abutments, 4.8mm, max 30°
  • · EV Series Dentsply® Implants Astratech Osseospeed®
  • · F Series Nobel Biocare NobelActive® NobelReplace® Conical
  • · H Series Biomet 3i Certain®
  • L Series Straumann Bone Level
  • · N Series Straumann Soft tissue Level
  • · R Series Zimmer Dental Tapered Screwvent®
• Medentika Multi Unit Abutments, 4.8mm, 0°
  • E Series Nobel Biocare Replace™ Select
  • · I Series Biomet 3i Osseotite®
  • K Series Nobel Biocare™ Branemark
  • · S Series Astra Tech OsseoSpeedTM
  • · T Series Dentsply Friadent® Frialit/Xive®
• · MegaGen Multi Unit Abutments, 4.8mm, max 30°
• · Xpeed® AnyRidge® Internal Implant System
• AnyOne® Internal Implant System
• AnyRidge® Octa 1 Implant System
• AnyOne® External Implant System
• AnyRidge® Octa 1 Implant System
• AnyOne® Internal Implant System
• Rescue Internal Implant System
• MIS Multi-unit Abutments, 4.8mm
  • · C1 Conical Connection Implant System, max 30°
  • · V3 Conical Connection Implant System, max 30°
  • · Internal Hex Implant System, max 30°
  • · Conical Connection, max 30°
• · Neodent GM Mini Conical Abutment, 4.8 mm, max 30°
• · Nobel Biocare™ Brånemark Multi Unit Abutment, 4.8 mm, max 17°
• · Nobel Biocare™ Multi Unit Abutment Plus, 4.8 mm, max 30°
• · Nobel Biocare™ Multi Unit Abutment, 4.8 mm, max 30°
• Nobel Biocare™ Multi Unit Abutments for Straumann and Astra Tech System, 4.8 mm, max 30°
• Nobel Biocare™ Multi Unit Abutments for Astra Tech, Camlog and Ankylos Implant Systems, 4.8 mm, max 30°
• · Nobel Biocare Xeal Abutments, 4.8 mm, max 30°
• · OSSTEM Multi Unit Abutment, 4.8mm, max 30°
  • SS SA Fixture Implants
  • SA Implant System
  • · ET US SSS Prosthetic System
• · Paltop Multi Unit Abutment, 5.0 mm, max 17°
• · Southern Compact Conical Abutments, 4.8 mm
  • MAX Implant System, 0°
  • · Provata Implant System, max 30°
  • · Deep Conical (DC) Implants, 0°
  • · Piccolo Implants, 0°
  • · External Hex Implants, max 30°
• Straumann® BLX Screw Retained Abutment, 4.6 mm, max 30°
• · Straumann® Screw Retained Abutment, 4.6 mm, max 30°
• · Zimmer Angled Tapered Abutments, 4.5 mm, max 30°

The Osteon Precision Milled Suprastructures (also referred to as superstructures) are metallic dental restorative devices that are intended to be attached by screw retention to dental implant abutments to aid in the treatment of partial and totally edentulous patients for the purpose of restoring chewing function. These suprastructures attach to dental implant abutments using the prosthetic screws from the original equipment manufacturers (OEM) and are used to support the final multi-unit restoration.

The Osteon Precision Milled Suprastructure is designed for an individual patient from scans of the patient's dental impression. The suprastructure is manufactured with the aid of Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) technology. All CAD/CAM fabrication is performed by Osteon Medical.

Osteon Precision Milled Suprastructures facilitate the attachment of both removable and fixed dental prosthesis and hence are categorized as Type A and Type B.

• Type A: Intended to act as a supporting structure to facilitate the attachment of a removable dental prosthesis and include Primary Bar and Nexus Removable Bar.
• . Type B: Intended to act as a supporting structure to facilitate the attachment of a fixed dental prosthesis and include Melbourne Bar and Nexus Fixed Bar (including Nexus Hybrid, Nexus Bridge, Micro Nexus, and Nexus Wraparound).

The provided FDA 510(k) summary (K233083) describes the acceptance criteria and study for the Osteon Precision Milled Suprastructure.

1. Table of Acceptance Criteria and Reported Device Performance

This submission is a 510(k) for an expansion of an existing device (K221019) to add compatibility with new OEM abutment systems and introduce three new Type B Nexus Fixed Bars. The acceptance criteria are primarily based on demonstrating substantial equivalence to the predicate devices in terms of intended use, technological characteristics, and material composition.

The tables below synthesize the design specifications (acceptance criteria) and the device's performance (reported as meeting these specifications) by demonstrating substantial equivalence to predicate devices.

Table 1: Comparison of General Characteristics and Materials (summarized for clarity)

Table 2: Design Specifications (Acceptance Criteria vs. Reported Performance)

*Note for Suprastructure Height: The Minimum Suprastructure Height for the Micro Nexus Bar (a new Type B bar in the subject device) is 2.5 mm, which is within the stated range of 3*-22 mm, where * indicates variability for this new bar.
**Note for Suprastructure Width: The Minimum Suprastructure Width for the Micro Nexus Bar (a new Type B bar in the subject device) is 2.5 mm, which is within the stated range of 3.4**-12 mm, where ** indicates variability for this new bar.

2. Sample size used for the test set and the data provenance

The submission is a 510(k) for an expansion of an existing device (K221019). The "study" proving the device meets acceptance criteria primarily relies on non-clinical data and demonstration of substantial equivalence to predicate devices.

• Test set/Sample size: The document does not describe a "test set" in the traditional sense of a clinical or imaging study with a defined sample size for statistical analysis. Instead, it relies on:
  • Reverse engineering analysis of OEM abutments and OEM abutment screws: This was done to confirm compatibility. The sample size for this analysis is not explicitly stated but would involve the specific OEM abutments listed for compatibility with the subject device.
  • Fatigue testing: The document states, "Fatigue testing was not performed since the Subject devices are abutment-borne and are not intended to compensate for angulation in excess of the maximum angulation of OEM angled abutments..." This indicates that engineering analysis and design specifications, rather than physical fatigue testing, were used to demonstrate performance in this regard.
• Data provenance: Not directly applicable as there isn't a "test set" from patients. The data relies on engineering analysis, existing predicate device data, and compliance with standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study requiring expert readers to establish ground truth. Substantial equivalence claims are based on engineering, material, and design comparisons to legally marketed devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no "test set" or diagnostic performance study that would require an adjudication method.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical dental suprastructure, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a physical dental suprastructure, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" equivalent for this submission is the established safety and effectiveness of the primary predicate device (K221019) and various reference devices, supported by:

• Compliance with recognized standards: Biocompatibility (ISO 10993-5, ISO 10993-12), sterilization validation (ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2, ANSI/AAMI/ISO 14937).
• Material specifications: Conformance to ASTM F136 for titanium alloy.
• Engineering analysis and design specifications: Comparison of design features to predicate devices and confirmation of compatibility through reverse engineering.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As above, there is no training set for this device.

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