(181 days)
BIOMET 3i Dental Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained to the abutment.
BIOMET 3i Encode Patient Specific Abutment for Nobel Active Connection can be compared to current Encode Patient Specific Abutment for Straumann Bone level Connection. The change to this device is only to the connection that is intended to interface which is identical to the interface found on the Nobel Active Internal Connection Implant. This feature does not modify the intended functionality of the implant/abutment system. This device is also intended for dental laboratories to provide limited design input to match the anatomical requirements of the patient.
The device is the Encode Patient Specific Abutment for Nobel Active Connection. The study conducted was Design Verification Testing according to ISO 14801:2007 "Dentistry -- Dynamic Fatigue Test for Endosseous Dental Implants".
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meets mechanical properties recommendations by FDA as outlined in "Guidance for Industry and FDA Staff: - Special Controls Class II -Standards: Root Form Endosseous Dental Abutment/ Implant" | Bench Testing conducted in accordance with the FDA Guidance document demonstrates that the proposed device meets the mechanical properties recommendations by FDA. |
| Meets the requirements of ISO 14801:2007 "Dentistry -- Dynamic Fatigue Test for Endosseous Dental Implants" | All testing conducted met the acceptance criteria and evaluated the worst-case scenario, including 30° pre-angled abutments as compared to predicate BIOMET 3i designs commercially in the marketplace. |
| Substantially equivalent to predicate devices (K071370 and K112730) in terms of intended use, indications for use, technological characteristics, and principles of operation. | The device has the same intended use, indications for use, and similar technological characteristics and principles of operation as the predicate devices. The major technological difference (connection interface) was also evaluated and found to be safe and effective. |
2. Sample Size and Data Provenance for Test Set:
The document does not specify the exact sample size used for the Design Verification Testing (test set). It mentions "all testing conducted" and "worst-case scenario including 30° pre-angled abutments". The data provenance is internal testing conducted by BIOMET 3i, presumably in the USA. The data is prospective in the sense that the testing was performed specifically for this submission to demonstrate compliance.
3. Number of Experts and Qualifications for Ground Truth:
This section is not applicable. The study involved bench testing with physical devices and standards, not clinical data requiring expert human assessment for ground truth.
4. Adjudication Method:
This section is not applicable, as the study involves bench testing of physical devices against predefined standards, not human assessment of data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This section is not applicable. This is a 510(k) submission for a medical device (dental implant abutment) and involves bench testing to demonstrate mechanical performance and substantial equivalence, not a clinical study involving human readers or AI assistance.
6. Standalone (Algorithm Only) Performance Study:
This section is not applicable. This is a physical medical device, not a software algorithm.
7. Type of Ground Truth Used for Test Set:
The ground truth for the test set was defined by regulatory standards and guidelines, specifically:
- ISO 14801:2007 "Dentistry -- Dynamic Fatigue Test for Endosseous Dental Implants"
- FDA Guidance Document: "Guidance for Industry and FDA Staff: - Special Controls Class II -Standards: Root Form Endosseous Dental Abutment/ Implant"
8. Sample Size for Training Set:
This section is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The study references predicate devices and prior BIOMET 3i designs, which broadly serve as a basis for comparison, but not a formally defined training set in the context of an algorithm.
9. How Ground Truth for Training Set Was Established:
This section is 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.)