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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 |
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(151 days)
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.
PreFace Abutment 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. PreFace Abutments are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations.
The purpose of this submission is to expand the Neodent Implant System components cleared under K101945, K123022, and K133592; these submissions included dental implants with a Morse taper abutment interface, mating abutments, abutment screws, and other associated components. This submission includes the Titanium Base Abutment, provided in two prosthetic platform diameters (3.5 and 4.5 mm), each in five gingival heights (0.8, 1.5, 2.5, 3.5 and 4.5 mm). Titanium Base is an abutment to be used as a base when fabricating a zirconia superstructure. This submission also includes the PreFace Abutment in two overall (milling) diameters of 11.5 and 15.8 mm. The PreFace Abutment with overall (milling) diameter of 15.8 mm is only used to mill an angled abutment.
PreFace is an abutment to be used in fabricating a full custom abutment in titanium alloy. After milling the minimum wall thickness for the PreFace must be no less than 0.4 mm, and the emergence profile diameter must be at least 3.3 mm. The maximum limit for angulation is 30°, and the maximum gingival height is 6 mm from the implant platform. In the case of an angled abutment, the cementable height from the emergence profile (prosthetic height) must not exceed 6 mm. The total height of the abutment (above the implant-abutment connection platform) must be no greater than 14.2 mm and no shorter than 4 mm. The range for the abutment body diameter (above the implant-abutment connection platform) is 3.3 mm. The implant interface must remain intact and cannot be modified.
The subject abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The subject abutments are compatible with Neodent dental implants having the Morse taper interface cleared in K101945, K123022 and K133592.
The provided text is a 510(k) Summary for the Neodent Implant System. It describes a medical device approval and focuses on demonstrating substantial equivalence to existing predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with defined performance metrics, ground truth, or expert consensus.
Therefore, many of the requested elements regarding acceptance criteria, study design, expert qualifications, and ground truth are not present in this type of regulatory document.
However, I can extract information related to performance data and comparison to predicate devices, which serve as a form of "acceptance criteria" in the context of substantial equivalence.
Here's an attempt to answer your request based on the provided document:
1. A table of acceptance criteria and the reported device performance
In the context of a 510(k) submission, "acceptance criteria" are typically demonstrating substantial equivalence to legally marketed predicate devices through comparison of technological characteristics and performance data. The reported "performance" is that the new device is at least as good as, or substantially equivalent to, the predicates.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use Equivalence | The subject device and the primary predicate devices have substantially equivalent indications for use, including providing support for customized prosthetic restorations. |
| Design and Function Equivalence (Titanium Base Abutment) | The subject Titanium Base abutments are substantially equivalent in design, function, size, and material to the Straumann CARES Variobase Abutments (K120822). They are both titanium alloy bonding bases for CAD/CAM zirconia superstructures. |
| Design and Function Equivalence (PreFace Abutment) | The subject PreFace abutments are substantially equivalent in design, function, size, and material to the Straumann C.A.R.E.S. Titanium Abutment (K052272). Both are abutment blanks for CAD/CAM fabrication of a custom titanium alloy abutment. Each has a precision implant-abutment interface compatible with specific implant systems. |
| Material Equivalence | The subject device uses Ti-6Al-4V, while predicate devices use Ti-6Al-7Nb. This is considered a "minor difference" but is justified by mechanical testing. |
| Mechanical Strength (Fatigue Testing) | Mechanical test results demonstrated that the strengths of subject Titanium Base and PreFace abutments are equal to or greater than that of predicate abutments in K120822 and K133421, respectively. (Performance: Fatigue testing according to ISO 14801). |
| Biocompatibility | Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include biocompatibility. (Performance/Finding: Biocompatible, assumed to meet relevant standards). |
| Sterilization | Sterilization testing was performed according to ISO 17665-1 and ISO 17665-2. (Performance/Finding: Sterilizable using moist heat, assumed to meet standards, and packaging similar to predicates). The device is "to be sterilized using the same processes" as predicate devices. |
| Operating Principle | The device uses the same operating principle as predicate devices. |
| Basic Design | The device incorporates the same basic design as predicate devices. |
| Packaging | The device has similar packaging to predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the document. The performance data mentioned are "non-clinical" (biocompatibility, engineering analysis, dimensional analysis, mechanical testing, sterilization testing). For mechanical testing (ISO 14801), sample sizes are not detailed, but such standards typically require a specific number of samples for statistically valid testing.
- Data Provenance: The document does not specify the country of origin of the data. It is a premarket notification from a Brazilian manufacturer (JJGC Indústria e Comércio de Materiais Dentários SA) to the U.S. FDA, meaning the testing data would typically be generated by or for the manufacturer. The data is non-clinical, likely from laboratory testing. It is not clinical data (no "retrospective or prospective" clinical studies are mentioned).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not applicable and not provided in the document. The document describes a medical device (dental implant abutments) that undergoes non-clinical engineering and material testing, not diagnostic performance evaluation requiring ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable and not provided in the document. Adjudication methods are typically used in clinical studies or performance evaluations where there's subjectivity and disagreement among reviewers (e.g., in imaging interpretation). The tests described are objective, non-clinical tests (e.g., mechanical fatigue, sterilization parameters).
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
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/imaging devices that assist human interpretation, which is not the nature of the dental implant abutments described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone (algorithm only) performance study was not done. This is not an AI/algorithm-based device. The "performance data" refers to the physical and material properties of the abutments.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- This information is not applicable and not provided in the document as it pertains to non-clinical engineering and material testing. The "ground truth" for mechanical testing, for example, would be the physical measurement of failure points or fatigue limits compared against a standard. For biocompatibility, it's compliance with ISO standards.
8. The sample size for the training set
- This information is not applicable and not provided in the document. There is no AI or algorithm involved that would require a "training set."
9. How the ground truth for the training set was established
- This information is not applicable and not provided in the document as there is no training set mentioned.
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