(183 days)
Indications for Use for GM Helix Implants and conventional abutments:
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.
Indications for Use for GM Exact Titanium Block for Medentika Holder:
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 cement-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.
Indications for Use for GM Exact Titanium Base abutments:
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.
Indications for Use for Titanium Base C for GM Exact abutments:
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 purpose of this submission is to expand the Neodent Implant System - GM Line components cleared under K163194, which included dental implants with a Morse taper abutment interface (called Grand Morse, or GM), mating abutment screws, and other associated components. This submission includes: GM Helix Implant in diameter (6 mm), overall lengths of 8 mm to 13 mm, and in two endosseous surfaces, grit-blasted and acid etched (NeoPoros) and hydrophilic surface (Acqua); GM Customizable Healing Abutment in two prosthetic diameters (5.5 mm and 7.0 mm), each in multiple gingival heights (ranging from 1.5 mm to 6.5 mm); GM Exact Titanium Block for Medentika Holder titanium blank abutment, in two milling diameters, 11.5 mm and 15.8 mm; GM Exact Titanium Base in one prosthetic diameter (5.5 mm), six gingival heights (from 0.8 mm to 5.5 mm), and two prosthetic post heights (4 mm and 6 mm); and Titanium Base C for GM Exact one prosthetic diameter (4.65 mm), 6 gingival heights (from 0.8 mm to 5.5 mm), and one prosthetic post height (4.7 mm).
The GM Exact Titanium Base and Titanium Base C for GM Exact are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis; the GM Exact Titanium Base and Titanium Base C for GM Exact are two piece abutments used as a base when fabricating a CAD/CAM customized restoration. The GM Exact Titanium Base C for GM Exact are provided in an anti-rotational shape for the coupling with the prosthesis and are available in diameters of 4.65 mm (Titanium Base C for GM Exact) and 5.5 mm (GM Exact Titanium Base), and the following gingival heights: 0.8, 1.5, 2.5, 3.5, 4.5, 5.5 mm. The planning and milling of the customized superstructures must be made using the validated Dental Wings Operating System (DWOS) or 3Shape software. All digitally designed copings and/or crowns for use with the GM Exact Titanium Base and Titanium Base C for GM Exact are intended to be manufactured at a validated milling center. The limits for customization are stated in the GM Exact Titanium Base and Titanium Base C for GM Exact product IFU. The superstructure produced through CAD/CAM System will compose the second part of the two-piece abutment; the assembly becomes a finished medical device after cementation on the GM Exact Titanium Base or Titanium Base C for GM Exact. The GM Exact Titanium Base is indicated for screw-retained single-unit, or cement-retained single or multi-unit prosthesis attachment onto implants. The Titanium Base C for GM Exact is indicated for cement-retained single-unit prosthesis attachment onto implants.
The subject device abutments components mate exclusively with the GM implants cleared in K163194.
The provided text is a 510(k) Summary for the Neodent Implant System - GM Line. It outlines the device's indications for use, description, and a comparison to predicate devices to demonstrate substantial equivalence, rather than directly detailing acceptance criteria and performance data in the format requested.
Here's an analysis based on the information provided, trying to extract details relevant to your request, but please note that some of your requested information might not be explicitly present in this type of FDA submission summary:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" with numerical targets and reported performance outcomes in the way one might expect for an AI/ML device. Instead, it focuses on demonstrating substantial equivalence to predicate devices through comparisons of indications for use, technological characteristics, and performance data from non-clinical studies (e.g., mechanical testing).
The "performance data" reported are primarily focused on safety and mechanical integrity, rather than a clinical performance metric.
| Acceptance Criteria (Implied by equivalence to predicate) | Reported Device Performance (Non-clinical Data) |
|---|---|
| Sterilization validated | Sterilization validation according to ISO 11137-1, ISO 11137-2, ISO 11135, ISO 10993-7, ISO 17665-1, ISO 17665-2. (Referenced from K163194) |
| Low bacterial endotoxin levels | Bacterial endotoxin according to AAMI/ANSI ST72. (Referenced from K163194) |
| Sterile barrier shelf life maintained | Sterile barrier shelf life testing (accelerated aging per ASTM F1980; seal integrity per ASTM E499/E499M, ASTM F1929; seal strength per ASTM F88/F88M; sterility of package contents per ISO 11737). (All referenced from K163194) |
| Biocompatibility | Biocompatibility (referenced from K163194; materials are identical to predicate devices). |
| Mechanical strength/fatigue resistance (implants) | Dynamic compression-bending testing according to ISO 14801 performed on worst-case subject device constructs (GM Exact Titanium Base, 5.5 mm diameter, 0.8 mm gingival height). Results demonstrated fatigue performance substantially equivalent to predicate device K163194. |
| Dimensional accuracy & fit | Engineering analysis; dimensional analysis. (Details of findings not explicitly stated, but implied to be acceptable for equivalence). |
2. Sample size used for the test set and the data provenance
The document indicates that no clinical data were submitted in this premarket notification. The "test set" for performance was based on non-clinical data, primarily engineering and mechanical testing.
- Sample size for mechanical testing (ISO 14801): Not explicitly stated in terms of number of samples, but implied to be sufficient for demonstrating compliance with the standard and substantial equivalence. The document mentions "worst-case subject device constructs."
- Data provenance: Non-clinical (laboratory testing). No information on country of origin of data, as it's not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as there was no clinical study and thus no "ground truth" established by human experts in the context of diagnostic or interpretive performance. The ground truth for mechanical testing is defined by the test standards (e.g., ISO 14801 parameters).
4. Adjudication method for the test set
This information is not applicable as there was no clinical study involving human judgment requiring an adjudication method.
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
This information is not applicable. The device is an endosseous dental implant system, not an AI-assisted diagnostic or interpretive device. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical medical device (dental implants and abutments), not an algorithm or AI system.
7. The type of ground truth used
The "ground truth" for the performance evaluation in this submission is established through:
- International standards and regulatory guidelines: For sterilization (ISO 11137 series, ISO 11135, ISO 10993-7, ISO 17665-1, ISO 17665-2), bacterial endotoxin (AAMI/ANSI ST72), sterile barrier shelf life (ASTM F1980, ASTM E499/E499M, ASTM F1929, ASTM F88/F88M, ISO 11737), biocompatibility (ISO 10993 series, implied by referencing K163194), and mechanical testing (ISO 14801).
- Comparison to predicate devices: Demonstration of identical or similar materials, design, and intended use as legally marketed devices.
8. The sample size for the training set
This information is not applicable as there is no AI/ML component or "training set" in the context of this physical medical device.
9. How the ground truth for the training set was established
This information is not applicable as there is no AI/ML component or "training set" in the context of this physical medical device. The "ground truth" for demonstrating substantial equivalence of the physical components is based on established engineering principles, materials science, and conformity to relevant international standards, effectively using the performance of the predicate devices as a benchmark for what is considered safe and effective for the described indications.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.