(186 days)
ArgenIS Titanium Abutments are intended to be single use available by prescription only in the construction of dental restorations supported by the endosseous dental implant. The ArgenIs Titanium Abutments are designed to specifically fit an individual patient's needs of the final restoration. All digitally designed abutments files are intended to be sent to Argen manufacturer for milling. The ArgenIS Titanium Abutments are compatible with the following implant systems:
| IMPLANT BRAND
NAME | PLATFORM | Manufacturer | Implant Trade
Name | Implant
Line/Connection | Implant
Diameter |
|---------------------------------|-----------|--------------------------|---------------------------------------------------|--------------------------------------------------------------|------------------------------|
| Nobel Biocare Replace
Select | 6.0mm | Nobel Biocare USA | Nobel Replace
Tapered
Conical
Connection | Nobel Replace
Internal Conical
Connection WP | 6.0mm |
| Nobel Biocare Active | 3.5mm | Nobel Biocare AB | NobelActive
Internal
Connection
Implant | Nobel Active
Internal Conn.
RP and NP | 3.0, 3.5, 4.3,
5.0mm |
| Nobel Biocare Active | 4.3/5.0mm | Nobel Biocare AB | NobelActive
Internal
Connection
Implant | Nobel Active
Internal Conn.
RP and NP | 3.0, 3.5, 4.3,
5.0mm |
| Straumann Bone Level | 3.3mm | Straumann USA | Straumann
Bone Level
Tapered
Implants | Bone Level
Internal Conn.
NC | 3.3mm |
| Straumann Bone Level | 4.1/4.8mm | Straumann USA | Straumann
Bone Level
Tapered
Implants | Bone Level
Internal Conn.
RC | 4.1, 4.8mm |
| Straumann Synocta | 4.8mm | Institut Straumann
AG | Straumann
Dental Implant | Synocta Implant
Internal Conn.
4.8mm RN (Reg.
Neck) | 4.8, 6.5mm |
| Straumann Synocta | 6.5mm | Institut Straumann
AG | Straumann
Dental Implant | Synocta Implant
Internal Conn.
6.5mm (Wide
Neck) | 4.8, 6.5mm |
| Astra Tech OsseoSpeed | 3.5/4.0mm | Astra Tech AB | AstraTech
Implant
OsseoSpeed | OsseoSpeed
Internal Conical
Connection RP | 3.6, 4.2, 4.8mm |
| Astra Tech OsseoSpeed | 4.5/5.0mm | Astra Tech AB | AstraTech
Implant
OsseoSpeed
Plus | OsseoSpeed Plus
Internal Conical
Connection RP | 3.0, 3.5, 4.0, 4.5,
5.0mm |
Argen IS Titanium Abutments are designed specifically for an Individual patient and then milled from a Titanium blank with a pre-milled interface correlating to a specific implant system. This abutment can be fixed in the laboratory model work containing the implant analog for final construction of the related prosthetic restoration. The Argen IS Titanium Abutments are then intended to be fixed in the mouth with the included prosthetic screw. The Argen IS Titanium Abutments are supplied with 2 screws (1) A Final Screw for fixing to the endosseuos Implant. (2) A lab screw for Laboratory use during construction of related restoration to avoid any damage to the final prosthetic screw will be marked "final Screw". The final screw must be torqued on the endosseuos Implant with the specific torque setting provided. The device is finalized at the Argen facility and provided to the dental laboratory in a final patient specific form.
Minimum and Maximum Gingival Height is 0-6mm
Minimum diameter at abutment/implant interface is 3.5mm to interface base
Maximum length of abutment from abutment/implant interface is 12.5mm
Minimum length of abutment post (length above the abutment collar/gingival height) is 4.0mm.
Minimum wall thickness at abutment/implant interface is 0.65mm
Maximal angle in relationship to the long axis of implant is 30°
The available range of diameters and connection type is summarized on the table below:
This document describes a 510(k) premarket notification for the "ArgenIS Titanium Abutments" by Argen Corporation. This type of regulatory submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets specific acceptance criteria through a clinical study or performance goals with clinical outcomes. Therefore, much of the requested information (like expert ground truth, adjudication methods, MRMC studies, training set details, or effect size of human readers with AI assistance) is not applicable to this type of device and submission.
Here's an analysis of the provided text in relation to your request, highlighting what can and cannot be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the format of a clinical trial or performance study with numerical targets and achieved results. Instead, it demonstrates substantial equivalence by comparing the device's technical characteristics and performance to predicate devices. The "performance" in this context refers to bench testing to ensure functional compatibility and mechanical integrity, not clinical outcomes.
| Feature | Acceptance Criteria (Implied / Predicate Comparison) | Reported Device Performance |
|---|---|---|
| Material | Predicate devices use Titanium-6AL-4 Vanadium ELI Alloy or CP Titanium. | ArgenIS Titanium Abutments use Titanium-6AL-4 Vanadium ELI Alloy. (Consistent with predicate K143051 and functionally equivalent to CP Titanium for this application). |
| Intended Use | Similar to predicate devices: construction of dental restorations supported by endosseous dental implants, single use, prescription only, designed to fit individual patient needs. | ArgenIS Titanium Abutments share the same intended use: single-use, prescription-only for dental restorations supported by endosseous dental implants, designed for individual patient needs. "Minor changes in descriptive terms used in the indications for use do not change the intended use of the proposed device." |
| Prosthetic Connection | Compatibility with specific implant systems (Nobel Biocare, Straumann, Astra Tech) as listed for predicate devices and the new device. | ArgenIS Titanium Abutments are compatible with a range of Nobel Biocare, Straumann, and Astra Tech implant systems, similar to the scope covered by the various predicate devices. |
| Implant Diameters/Lengths | Within the range of existing predicate devices. | ArgenIS supports diameters 3.3mm, 3.5mm, 4.0mm, 4.1mm, 4.3mm, 4.5mm, 4.8mm, 6.0mm, 6.5mm, which are covered by the collective range of the predicate devices. |
| Type of Retention | Screw-retained to the implant; prosthesis cement-retained to the abutment, consistent with predicate devices. | ArgenIS Titanium Abutments are screw-retained to the implant, with the prosthesis cement-retained to the abutment. (Identical to all predicates shown). |
| Manufacturing Process | Machining, consistent with predicate devices. | ArgenIS Titanium Abutments are manufactured via machining. (Identical to all predicates shown). |
| Abutment Sterilization | Moist Heat (Steam), consistent with predicate devices. | ArgenIS Titanium Abutments use Moist Heat (Steam) for sterilization. (Identical to all predicates shown). |
| Abutment Angulation | Within the range of predicate devices (0°-30°). | ArgenIS Titanium Abutments have an angulation range of 0° - 30°. (Consistent with primary predicate K143051, and overlaps with/encompasses other predicates' ranges). |
| Dimensional Compatibility | Demonstrated through tolerance analysis and functional fit checks. | "Testing included tolerance analysis to ensure abutment/implant interface compatibility. Functional fit checks of abutment blank to compatible implant and prosthetic screw. Testing showed correct functionality of the device as per its intended use, including dimensional compatibility, and mechanical performance." |
| Mechanical Performance (Fatigue) | Conformance to ISO 14801 for worst-case scenarios (smallest diameter, shortest length from each platform). This implicitly means meeting at least the performance levels of predicate devices that would also conform to ISO 14801. | "Fatigue testing was conducted on worst case scenario samples. Worst case scenario was defined as the smallest diameter and shortest length from each platform. The worst case scenarios from each of the proposed platforms were tested per ISO 14801." (The document asserts conformance to performance specifications, implying successful completion of these tests in line with relevant standards and predicate performance). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document mentions "worst case scenario samples" for fatigue testing but does not specify the exact number of samples. This is typical for bench testing where the focus is often on specific critical configurations rather than a large statistical sample of all possible configurations.
- Data Provenance: This was "Non-clinical test data" from "Bench testing." As such, there is no country of origin for patients or retrospective/prospective classification. It's laboratory data.
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)
Not applicable. This device is an implant abutment, and the testing involved engineering/mechanical validation (bench testing), not clinical diagnosis or interpretation requiring expert human judgment for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no human expert adjudication of test results in the clinical sense. Performance was determined by objective measurements during bench testing against engineering specifications and standards.
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 dental implant abutment, not an AI 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 medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on engineering specifications, material properties, and relevant international standards (e.g., ISO 14801). For compatibility and fit, it's about precise dimensional measurements and physical mating tests against the actual or specified dimensions of compatible implant systems.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device.
§ 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.)