(140 days)
Multi Angled Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as bridges, or overdentures.
The Multi Angled Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration. The Multi Angled Abutment is used with Esthetic -low Cylinders (only Non-Hex) in the US System. K62030 and connected to HTIII SA Fixture in the HT3 SA Fixture System, K101096. The Multi Angled Abutment consists of Abutment and Abutment Screw. The Multi angle Abutment is used to elevate restoration platform when restoration to implant level is not practical due to depth or angle of implant for the edentulous patients in Anterior and Posterior, not customizable and can't be use a single product.
This document describes the K12-3755 Multi Angled Abutment, a dental device. The 510(k) summary provided does not contain the typical details of a study proving a device meets acceptance criteria as this is a premarket notification for substantial equivalence. Instead, it focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device.
Here's an analysis based on the provided text, addressing the points where information is available and noting where it is not relevant or not provided for this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission seeking substantial equivalence for a dental abutment, the "acceptance criteria" are primarily established by demonstrating equivalency in material, design, function, and intended use to a predicate device, and ensuring safety through non-clinical testing. Performance is measured against the predicate.
| Feature/Test | Acceptance Criteria (Implicit from Predicate) | Reported Device Performance (Multi Angled Abutment) |
|---|---|---|
| Material Composition | Same as predicate (Titanium alloy) | Made of the same material (Titanium alloy) |
| Manufacturing Process | Same as predicate | Same manufacturing process |
| Chemical Composition | Same as predicate | Same chemical composition |
| Body Contact | Same as predicate | Same body contact characteristics |
| Intended Use | "For use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures." (Predicate: K110308) | "Intended for use with a dental implant to provide support for prosthetic restorations such as bridges, or overdentures." (Slight wording difference, but identical core intent) |
| Design Characteristics (Dimensions) | Predicate dimensions: A(°): 17, 30; B(mm): 5, 5.1, 5.5, 5.6, 6, 6.1, 6.5, 6.6, 7.5, 7.6; C(Ø): 2.84, 2.88, 3.39, 3.43; D(Ø): 4.9 | Multi Angled Abutment dimensions: A(°): 17, 30; B(mm): 3.17, 3.4, 4.17, 4.4, 4.76, 4.86, 5.17, 5.4, 5.76, 5.86, 6.76, 6.86; C(Ø): 2.88, 3.43; D(Ø): 4.8. (Note: different range of 'B' and 'D' but within a similar functional context for dental abutments) |
| Connection (Abutment/Implant) | No modification to the abutment/implant connection compared to the predicate | No modification to the abutment/implant connection, no difference compared to predicate device (K110308) |
| Safety Tests | Compliance with applicable international and US regulations (biocompatibility, risk analysis, dimension inspection) | Biocompatibility considered, risk analysis and dimension inspection conducted. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This submission is for substantial equivalence and relies on non-clinical testing and comparison to a predicate device, not a human clinical trial with a "test set" in the traditional sense.
- Data Provenance: The manufacturer, OSSTEM Implant Co., Ltd., is located in Busan, Republic of Korea. The non-clinical testing data would originate from their internal processes or contracted labs. The data is "retrospective" in the sense that it's a comparison to an already marketed device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts & Qualifications: Not applicable. Ground truth for a clinical test set is not relevant for this type of 510(k) submission, which focuses on non-clinical aspects and comparison to a predicate device's established performance and safety record.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable for the reasons stated above.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
- MRMC Study: Not applicable. This device is a passive dental abutment, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This device is a physical dental component, not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" in this context is the established safety and effectiveness of the predicate device (Prosthetic System, K110308). The new device demonstrates substantial equivalence through material comparison, design comparison, non-clinical safety tests (biocompatibility, risk analysis, dimension inspection), and alignment of intended use. There is no pathology or outcomes data from a clinical study for this specific device.
8. The Sample Size for the Training Set
- Training Set Sample Size: 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
- Ground Truth for Training Set: Not applicable for the reasons stated above.
§ 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.)