(198 days)
The NobelProcera Ti Abutments Camlog Platforms are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the Camlog K series 3.3, 3.8, 4.3, 5.0 and 6.0 implants.
Nobel Biocare's NobelProcera Ti Abutment Camlog Platforms is an endosseous dental implant abutment. The abutment attaches directly to Camlog dental implants and provides a platform for restoration.
Nobel Biocare's NobelProcera Ti Abutments are designed and made individually to fit the individual requirements for each patient. The NobelProcera Ti Abutments are made entirely of titanium.
The abutments are compatible with the Camlog K series 3.3, 3.8, 4.3, 5.0, 6.0 implants,
This document describes the NobelProcera Ti Abutment Camlog Platforms, a premanufactured prosthetic component for dental implants. The information provided focuses on the regulatory submission (510(k)) and its basis for demonstrating safety and effectiveness.
1. Acceptance Criteria and Reported Device Performance
The device is a direct comparator to a legally marketed predicate device (Nobel Biocare - NobelProcera Ti Abutment (K091756)). The acceptance criteria for this type of device are primarily based on demonstrating substantial equivalence to the predicate, particularly concerning design, materials, and mechanical performance. The study conducted was non-clinical fatigue testing.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance/Findings |
|---|---|---|
| Design/Construction | Patient-specific / machined, similar to predicate | Matches Predicate: Patient specific / machined |
| Anatomical Site | Oral Cavity, similar to predicate | Matches Predicate: Oral Cavity |
| Device Material | CP Titanium, Titanium/vanadium alloy, similar to predicate | Matches Predicate: CP Titanium, Titanium/vanadium alloy |
| Indications for Use | Premanufactured prosthetic components, directly connected to endosseous dental implants, aid in prosthetic rehabilitation. Specific compatibility with Camlog K series 3.3, 3.8, 4.3, 5.0, 6.0 implants. | Substantially Equivalent with Specificity: The indications are premanufactured prosthetic components directly connected to endosseous dental implants and intended for use as an aid in prosthetic rehabilitation. The key difference from the predicate is the specific compatibility listed for Camlog K series implants (3.3, 3.8, 4.3, 5.0, 6.0), which differentiates it from the predicate's broader compatibility with Nobel Biocare, Astra Tech, Straumann, and BIOMET 3i implants. This specificity is a design difference, not a divergence from the fundamental intended use. |
| Mechanical Performance | Fatigue testing in accordance with FDA guidance "Class II, Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." | Met Standard: Non-clinical test data for fatigue testing was used to support the decision of safety and effectiveness, indicating the device performed acceptably under the specified guidance. The submission concludes that this demonstrates substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of human data or AI model evaluation. The study involved non-clinical performance of fatigue testing of the abutment. The sample size for this engineering testing is not explicitly stated but would typically involve multiple units to establish statistical confidence in the mechanical properties. The data provenance is non-clinical laboratory testing, not human data from a specific country.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the study was non-clinical fatigue testing, not a human reader study or clinical trial requiring ground truth established by medical experts.
4. Adjudication Method for the Test Set
This information is not applicable as the study did not involve human interpretation or a "test set" in the context of diagnostic performance that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The submission focuses on the substantial equivalence of a medical device (dental implant abutment) primarily through non-clinical mechanical testing, rather than evaluating the diagnostic or interpretative performance of human readers with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable. The device is a physical medical device (dental implant abutment), not an AI algorithm. Therefore, no standalone algorithm performance study was done.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established through engineering standards and physical measurements from the fatigue testing, as dictated by the FDA guidance for endosseous dental implants and abutments. It is not an expert consensus, pathology, or outcomes data in the usual sense of clinical studies.
8. Sample Size for the Training Set
This information is not applicable as the device is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as the device is a physical medical device, not an AI model.
§ 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.)