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510(k) Data Aggregation
(127 days)
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.
The Facility implant is indicated for replacement of maxillary lateral incisors, mandibular incisors or retention of overdentures.
Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations, or screw-retained single restorations.
All digitally designed copings and/or crowns for use with the Neodent Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.
The Pro PEEK Abutments are indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months. They can be used in one or two stage procedures and also immediate load when there is good primary stability.
GM Exact Titanium Block for Medentika Holder is a titanium abutment to be used in fabricating a full custom abutment and placed onto Neodent dental implants to provide support for customized prosthetic restorations. The GM Exact Titanium Block for Medentika Holder abutments are indicated for screw-retained single restorations or cemented-retained single or multi-unit restorations.
All digitally designed abutments for use with the GM Exact Titanium Block for Medentika Holder are intended to be sent to Straumann for manufacture at a validated milling center.
The Titanium Base C for GM Exact abutments is a titanium component that is placed over Neodent implants to provide support for custom prosthetic restorations, such as copings or crowns. It is indicated for single-tooth screw-retained restorations. All digitally designed copings and/or crowns for use with the Titanium Base C for GM Exact abutments are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.
The present submission is for an increase in the shelf life of the Neodent Implant System having the Acqua surface treatment; the shelf life is being extended from 2-years.
The subject devices are:
- Intended for single use;
- Provided sterile via gamma irradiation;
- Manufactured of commercially pure titanium grade 4;
- Root-form, threaded implants with Acqua surface treatment;
- Compatible with several implant-to-abutment interfaces of the Neodent Implant System as presented in the Comparison Tables below.
This section describes the acceptance criteria and the study that proves the specified device meets the acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Hydrophilicity (Dynamic Contact Angle) | Dynamic contact angle < 5° | Passed (0°) |
| Visual Evaluation | No abrasion, rips, creases, detachment, or any other non-compliance that affect the packaging performance or the readability of the labeling information. | Passed |
| Dye Penetration (ASTM F1929) | No dye solution leakage through the blister sealing. | Passed |
| Bubble Test (ASTM F2096) | No constant flow of bubbles in the sealed area of the blister indicating a failure area. | Passed |
| Sealing Strength Test (ASTM F88) | Present values of seal resistance between 1.5 N and 15 N for specimens with width of 15 ± 1 mm. | Passed |
| Cytotoxicity (ISO 10993-5) | Inhibition of proliferation less than 30% compared to untreated cultures (reagent control) | Passed |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test within the real-time aging study. The study is described as a "real-time aging study," which implies prospective data collection as the devices age over time. There is no information regarding the country of origin of the data provided in this document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of study (real-time aging and performance testing of a medical device for shelf-life extension) does not typically involve human experts establishing a "ground truth" in the way a diagnostic AI study would. The ground truth here is the objective measurement of physical and biological properties against established scientific and engineering standards and specifications. Therefore, this information is not applicable in the context of this device and study.
4. Adjudication Method for the Test Set
Not applicable. The tests performed are objective measurements against predefined criteria and standards (e.g., ASTM, ISO standards). There is no mention of human adjudication in the traditional sense.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is not an AI/medical imaging device. It is a dental implant seeking shelf-life extension, which is evaluated through physical, chemical, and biological performance testing. Therefore, an MRMC comparative effectiveness study is not relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This is not an AI/medical imaging device. The device itself (dental implant) is the subject of the performance testing, not an algorithm.
7. Type of Ground Truth Used
The ground truth for this shelf-life extension study is based on established scientific and engineering standards and specifications. This includes:
- Physical properties (e.g., hydrophilicity, visual integrity, sealing strength).
- Biological safety (e.g., cytotoxicity testing guided by ISO 10993-1, -5, -12).
- Maintenance of characteristics after accelerated aging and real-time aging.
8. Sample Size for the Training Set
Not applicable. As this is not an AI/machine learning device, there is no "training set" in the context of algorithm development. The "training" for shelf-life extension is the real-time aging process itself and the historical data from previous shelf-life clearances.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set as defined in AI/machine learning. The "ground truth" for evaluating the shelf-life extension is established by standardized testing protocols and acceptance criteria based on industry standards (ASTM, ISO) and scientific principles of material degradation and biological compatibility.
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