(160 days)
The Straumann® Magellan™ abutments are indicated to be placed into Straumann® dental implants to provide support for prosthetic reconstructions such as crowns, bridges and bars.
The final processed devices have the purpose of restoring chewing function.
Magellan™ abutments are indicated for screw-retained restorations.
This proposed Magellan™ Bone Level Abutment System is based upon the currently cleared Regular CrossFit® (RC) and Narrow CrossFit® (NC) screw-retained Bar and Bridge Abutment Line under premarket notification K080239. The Magellan product line includes one-piece straight abutments for the NC interface, straight and angled (17° and 30°) abutments for the RC interface, basal screws, occlusal screws, protective caps and titanium and gold restorative copings.
This submission, K133421 for the Straumann® Magellan™ Abutment System, is a Traditional 510(k) for a dental implant abutment. The review focuses on demonstrating substantial equivalence to predicate devices, rather than establishing clinical efficacy through direct performance testing with acceptance criteria in the typical sense of a diagnostic or therapeutic medical device.
Therefore, the "acceptance criteria" here are primarily based on equivalence to the predicate device's design, materials, and performance standards, specifically dynamic fatigue testing for dental implants.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (based on predicate equivalence and ISO standard) | Reported Device Performance |
|---|---|---|
| Technological Characteristics | ||
| Implant/Abutment Connection | Equivalent to predicate device's CrossFit® connection. | CrossFit® connection with anti-rotation feature. Deemed Equivalent: "Anti-rotation feature not required for bar and bridge constructs." |
| Diameter | Diameters of subject devices to be within the range of the predicate devices (RC: Ø4.0, 4.5, 6.5 mm; NC: Ø3.5, 4.5 mm). | RC: Ø4.6 mm, NC: Ø3.5, 4.6 mm. Deemed Equivalent: "The diameters of the subject devices are within the range of the predicate devices." |
| Gingival Height (GH) | Gingival heights offered to be within the range of the predicate devices (1.0 mm, 2.5 mm, 4.0 mm). | 1.0mm, 2.5 mm, 4.0 mm. Deemed Equivalent: "The gingival heights of the subject devices are within the range of the predicate devices." |
| Abutment Height | Abutment heights offered to be within the range of the predicate devices (1.0 mm, 4.6 mm). | 1.7 mm, 1.9 mm. Deemed Equivalent: "The abutment heights of the subject devices are within the range of the predicate devices." |
| Materials | ||
| Titanium-Aluminum-Niobium Alloy (Ti-6AI-7Nb) | Meeting the requirements of ISO 5832-11. | Manufactured from Ti-6AI-7Nb, meeting ISO 5832-11 requirements. |
| Gold Copings | Made from Ceramicor® alloy. | Made from Ceramicor® alloy. |
| Protective Caps | Made from Polyether Ether Ketone (PEEK). | Produced from PEEK. |
| Performance Testing | ||
| Dynamic Fatigue Performance | Expected to meet the requirements of ISO 14801 (Dentistry - Implants - Dynamic fatigue test for endosseous dental implants for abutment connection performance). The acceptance criteria for this standard typically involve testing a statistically significant number of samples to a specified load and number of cycles (e.g., 5,000,000 cycles for fatigue strength) without failure, or demonstrating fatigue strength at a level comparable or superior to the predicate device. | Bench testing per ISO 14801 was performed to evaluate the dynamic fatigue performance of the subject devices. The submission indicates this testing supports the conclusion of substantial equivalence; implicitly, the device met the performance requirements of the standard, thereby being equivalent to or better than the predicate's expected performance, given the lack of specific numerical criteria provided in the summary. |
2. Sample Size Used for the Test Set and Data Provenance
The submission describes bench testing for performance evaluation.
- Sample Size: Not explicitly stated in the provided text for each specific test within ISO 14801. ISO standards typically mandate a minimum number of samples for statistical significance in mechanical testing (e.g., 5-6 samples for each test condition for fatigue testing to determine a fatigue limit).
- Data Provenance: Bench test data, therefore, no country of origin for patient data. It is inherently retrospective in the sense that the testing was completed prior to submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This submission relates to a physical medical device (dental abutment) and its mechanical performance, not a diagnostic algorithm or image analysis requiring expert ground truth for interpretation. The "ground truth" for the performance criteria is defined by international engineering standards (ISO 14801).
4. Adjudication Method for the Test Set
Not applicable. There is no human interpretation or subjective assessment that would require adjudication for the bench test results. The results are objective measurements of mechanical properties.
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 is not an AI/software device and no human reader studies were conducted.
6. If a Standalone (i.e., algorithm-only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm-based device.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating device safety and effectiveness in this context is based on established engineering standards (ISO 14801) and equivalence to legally marketed predicate devices. The materials also conform to ISO 5832-11. There is no pathology, outcomes data, or expert consensus used for the "ground truth" in the way it's typically applied to diagnostic or prognostic devices.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is a physical medical device submission, not a machine learning or AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no "training set" or need for ground truth establishment for a training set.
§ 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.)