(119 days)
Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations, or screw-retained single restorations.
All digitally designed copings and/or crowns for use with the Neodent Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.
This submission includes the Titanium Base abutments (two-piece hybrid abutments) and the superstructures that compose the final abutment (the second part of the two-piece abutment).
The Titanium Base abutments are provided in two prosthetic platform diameters (3.5 and 4.5 mm), each in five gingival heights (0.8, 1.5, 2.5, 3.5 and 4.5 mm). They have a Morse taper implant-to-abutment interface and an additional hexagonal indexing feature at the apical end of the Morse taper connection. The surface is as-machined, without any type of treatment surface. The Titanium Base abutment is an intermediary prosthetic component between the implant and prosthesis; a CAD/CAM abutment design to be used as a base when fabricating a coping, crown or bridge superstructure. It is a stock abutment, previously cleared per K150367. The subject abutments are compatible with Neodent dental implants having Morse taper (CM) implant-to-interface cleared under K101945, K123022, K133592, K133592, K150182 and K150199.
The purpose of this submission is to expand the range of materials allowed in fabricating the superstructure, adding Co-Cr and IPS e.max "CAD materials to the previously cleared portfolio.
A dental laboratory equipped with an appropriate CAD system, will design a customized superstructure or restoration made of zirconia, IPS e.max CAD or Co-Cr. Each patient-specific superstructure is individually prescribed by the clinician. The minimum wall thickness of the structure is variable depending on the material, according to the table below. The maximum angling of the structure should not exceed 30°. The taper of the structure should not exceed 6°. In the case of a structure angled at the height of the cementable portion starting at the emergence profile (prosthetic height), it should not exceed 10 mm for the Morse Taper.
The provided text is a 510(k) Pre-Market Notification for a medical device (Neodent Implant System - Titanium Base Abutment) to the FDA. It details the device's characteristics and compares it to a predicate device to establish substantial equivalence. However, it does not describe an acceptance criteria table related to performance metrics for a study outcome using accuracy, sensitivity, or specificity, nor does it provide a study that proves the device meets such criteria in the context of an AI/ML or diagnostic device.
The document focuses on demonstrating that the new features of the Neodent Implant System (specifically, the expanded range of materials for superstructures: Co-Cr and IPS e.max CAD) are substantially equivalent to a previously cleared predicate device. The performance data presented are primarily engineering and sterilization validations, not clinical or diagnostic performance metrics.
Therefore, for aspects related to acceptance criteria and studies demonstrating device performance typically associated with AI/ML or diagnostic devices (such as sensitivity, specificity, or accuracy with ground truth validation), the information is not present in the provided text.
Here's an analysis of the information that is available based on your request:
1. A table of acceptance criteria and the reported device performance
No such table is provided in the document for performance metrics like accuracy, sensitivity, or specificity. The "acceptance criteria" for this submission are related to demonstrating substantial equivalence through:
- Identical Indications for Use (with minor wording differences considered equivalent)
- Identical Mechanical Design Parameters (Abutment Diameter(s), Implant-to-Abutment Connection, Compatibility, Mode of attachment, Restoration Angulation(s), Gingival Height(s))
- Identical Abutment Material (Titanium-aluminum-vanadium alloy Ti-6Al-4V)
- Equivalent Superstructure Materials (Addition of Co-Cr and IPS e.max CAD, arguing equivalence based on widespread dental use and existing predicate devices)
- Identical Sterility and Sterilization by End User
The reported device performance primarily revolves around non-clinical testing to support mechanical integrity, sterilization effectiveness, and biocompatibility.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Summary from document) |
|---|---|
| Mechanical Strength & Durability | Performed per ISO 14801; compliant with FDA Guidance. |
| Ethylene Oxide Sterilization | Validation per ISO 11135. |
| Steam Sterilization by End User | Validation per ISO 17665 series standards. |
| Biocompatibility | Supported by identical titanium base material to predicate and superstructure materials identical to reference predicates. |
| Material Properties (Superstructure) | Co-Cr and IPS e.max CAD are widely used in dental restorations and are used in Straumann reference predicates. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "engineering analysis, and dimensional analysis" and "mechanical testing," "sterilization validation." These are typically laboratory-based tests with specific sample sizes for specimens, but these details are not disclosed. No patient data (test set) is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as there is no diagnostic test set or ground truth established by experts described in this document. The submission is for a dental implant abutment, not an AI/ML or diagnostic device requiring expert interpretation of results.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as there is no diagnostic test set or adjudication process described.
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
This information is not applicable as the device is a dental implant abutment, not an AI-assisted diagnostic or imaging interpretation device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a physical medical device (dental implant abutment), not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable as there is no ground truth, expert consensus, pathology, or outcomes data used for performance evaluation in the context of diagnostic accuracy. The "ground truth" for this device's performance would be the physical properties and material specifications, which are assessed through engineering and bench testing.
8. The sample size for the training set
This information is not applicable as this is a physical medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as this is a physical medical device, not an AI/ML model.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)