(86 days)
The P.004 Implants are intended for immediate, delayed or conventional placement in the maxilla and/or mandibular arches to support crowns bridges or overdentures in edentulous or partially edentulous patients.
They are intended for immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, 4 or more implants must be used.
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. Meso abutments are indicated for cemented restorations particularly in esthetic areas of the mouth. The abutment can be used in single tooth replacements and multiple tooth restorations.
The P.004 Implant is an addition to the currently distributed Straumann Dental Implant System. The P.004 implant is a solid screw with a SLA (grit blasted then acid etched) or SLActive surface. The implants are composed of Grade 4 commercially pure Titanium and are available in a range of lengths and diameters.
This submission also includes a Titanium Meso abutment and healing caps which are used as accessories to dental implants.
This 510(k) summary (K062129) is for a dental implant (P.004 Implant) and related abutments. The document primarily focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting the results of a specific study proving device performance against acceptance criteria. Therefore, most of the requested information regarding study design and performance metrics cannot be found in this summary.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of performance metrics. The core "acceptance criteria" for a 510(k) submission are based on demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed equivalent. This typically involves comparing technological characteristics and intended use.
- Reported Device Performance: No specific performance metrics (e.g., success rates, torque values, osseointegration percentages) are reported in this summary. The summary states: "The subject implant has the same material composition and the same surface treatments as previously cleared Straumann implants. In addition, the design of the subject implant is similar to, and in some respects identical to, the previously cleared Straumann implant." This is a qualitative comparison for equivalence, not a quantitative performance report.
Table of Acceptance Criteria and Reported Device Performance (Based on Substantial Equivalence Basis):
| Acceptance Criteria (Implied for 510(k) Equivalence) | Reported Device Performance (from K062129) |
|---|---|
| Intended Use Equivalence | "The intended use is identical to the predicate device." (ITI Tapered Dental Implant, K012757) |
| Material Composition Equivalence | "The subject implant has the same material composition... as previously cleared Straumann implants." (Grade 4 commercially pure Titanium) |
| Surface Treatment Equivalence | "...and the same surface treatments as previously cleared Straumann implants." (SLA or SLActive surface) |
| Design Similarity | "The design of the subject implant is similar to, and in some respects identical to, the previously cleared Straumann implant." |
| Accessory Equivalence (Meso abutment) | "The subject Meso abutment... has the same intended use and is made of the same material as the previously cleared synOcta Meso Abutment." |
| Accessory Design Similarity | "The design of the subject abutment is substantially equivalent to the previously cleared predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable/Not provided. This 510(k) summary does not describe a clinical study with a test set. It relies on a comparison to predicate devices and their established safety and efficacy.
- Data Provenance: Not applicable.
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)
- Number of Experts/Qualifications: Not applicable. No "ground truth" was established in the context of a performance study described here. The safety and efficacy are inferred from substantial equivalence to predicate devices, which implies prior expert assessment and clinical use of those predicates.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. No test set requiring expert adjudication is 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
- MRMC Study: No. This is a medical device for implantation, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: No. This is not an algorithmic device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Type of Ground Truth: For the purpose of this 510(k), the "ground truth" is essentially the demonstrated safety and effectiveness of the predicate devices (ITI Tapered Dental Implant, K012757; ITI Dental Implant System, synOcta Meso Abutment, K033243) under their historical clinical use and regulatory clearances. There is no new, independent ground truth established for the P.004 Implants within this document.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This document does not describe the development or testing of an algorithm, so there is no training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.