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510(k) Data Aggregation
(216 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. The Neodent Implant System - Temporary Abutments are indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months.
- Temporary Abutment for provisional restoration employed for up to 6 months;
- Intended for single use;
- Provided sterile via ethylene oxide gas;
- Constructed of titanium alloy (Ti6Al4v-ELI) per ASTM F136;
- Coronal geometry has grooves to facilitate bonding of acrylic material;
- Abutment is screw-retained;
- Coronal geometry contains channels to facilitate reduction of abutment height;
- Provided in anti-rotational and rotational versions supporting single and multi-unit restorations, respectively;
- Provided in multiple gingival heights;
- Implant-to-abutment interface compatible with GM implants of the Neodent Implant System.
Here is the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria & Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria for device performance in a table format. Instead, it refers to performance data used to demonstrate substantial equivalence to a predicate device. The performance data is therefore related to demonstrating features or durability comparable to established standards and the predicate.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Fatigue Strength | Sufficient to withstand dynamic loading in the oral environment, demonstrating equivalence per ISO 14801 guidelines for worst-case implant construct with temporary abutments for multi-unit restorations. | Dynamic fatigue test per ISO 14801 was performed to determine the fatigue strength for the worst-case implant construct assembled with GM Temporary Abutments for multi-unit restorations, according to FDA Guidance. (Specific numerical result not provided, but implies satisfactory performance to demonstrate equivalence). |
| Torsional Strength | Sufficient to withstand static torsional loading for abutment screws. | Torsion testing was performed to evaluate the GM Temporary Abutments Screws under static torsional loading. (Specific numerical result not provided, but implies satisfactory performance to demonstrate equivalence). |
| Sterility | Sterility Assurance Level (SAL) of 1 x 10^-6 via ethylene oxide gas. | Sterilization of the subject abutments via ethylene oxide gas using the overkill method has been validated according to the requirements of ISO 1135. A minimum Sterility Assurance Level (SAL) of 1 x 10^-6 has been validated. |
| Ethylene oxide residuals have been assessed per ISO 10993-7. Residuals are within accepted limits. | ||
| Shelf Life | At least 5 years. | Accelerated and Real Time Aging tests were performed according to ASTM F1980. The Shelf Life of the subject devices is 5-years. |
| Biocompatibility | Biologically safe for temporary use in the human body. | Biological Safety Assessment guided by ISO 10993-1. |
| Cytotoxicity testing was performed per ISO 10993-5. | ||
| Chemical characterization was performed per ISO 10993-18. | ||
| Biocompatibility sample preparation was performed per ISO 10993-12. (Implies positive results showing biocompatibility and absence of cytotoxity within accepted limits). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes for each of the tests (dynamic fatigue, torsion, sterility, aging, biocompatibility). It only states that the tests were performed.
The data provenance is from JJGC Indústria e Comércio de Materiais Dentários SA (dba Neodent) located in Curitiba, Parana, Brazil. The studies are prospective in nature, as they involve performing tests and gathering data specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the studies described are performance tests (mechanical, sterilization, aging, biocompatibility) of a medical device, not diagnostic studies that require expert interpretation of results to establish ground truth (e.g., image interpretation by radiologists). The "ground truth" here is defined by objective physical and chemical standards (e.g., ISO and ASTM standards).
4. Adjudication Method for the Test Set:
This information is not applicable for the type of studies presented. Adjudication methods (like 2+1, 3+1) are typically used in clinical trials or studies where human interpretation of data is involved and discrepancies need to be resolved. The described studies are objective laboratory/engineering tests.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not performed. This type of study is typically conducted for diagnostic devices (e.g., AI in radiology) to assess the impact of AI on human reader performance. The device described (Temporary Abutments) is a physical implant component, not a diagnostic AI tool.
6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done:
This question is not applicable as the device is a physical medical device (temporary abutment), not an algorithm or AI system. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance studies conducted (fatigue, torsion, sterility, etc.) are inherently "standalone" in that they test the device itself.
7. The Type of Ground Truth Used:
The "ground truth" for the performance studies is established by objective technical standards and regulatory guidelines. This includes:
- ISO 14801 for dynamic fatigue.
- ISO 1135 for sterilization validation.
- ISO 10993-7 for ethylene oxide residuals.
- ASTM F1980 for accelerated and real-time aging.
- ISO 10993-1, 10993-5, 10993-18, 10993-12 for biocompatibility.
- FDA Guidance documents for specific test methodologies.
The "ground truth" is adherence to and performance within the limits or specifications set by these recognized standards to ensure safety and effectiveness comparable to legally marketed predicate devices.
8. The Sample Size for the Training Set:
This information is not applicable. The device is a physical medical device, not an AI model or algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as above; there is no "training set" for physical device performance.
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(116 days)
- HE (External Hex) implants, stock abutments and stock copings (originally cleared per K101207)
- Titamax CM (Cone Morse) implants, stock abutments and stock copings (originally cleared per K101945 ● and extended per K123022, K133696 and K150199)
- Titamax CM (Cone Morse) EX implants, stock abutments and stock copings (originally cleared per K101945 and extended per K123022, K133696 and K150199)
- Alvim CM (Cone Morse) implants, stock abutments and stock copings (originally cleared per K101945 and ● extended per K123022, K133696 and K150199)
- CM (Cone Morse) Drive implants, stock abutments and stock copings (originally cleared per K123022 and extended per K133696, K150182 and K150199)
- GM (Grand Morse) Titamax implants, stock abutments and stock copings (originally cleared per K163194)
- GM (Grand Morse) Drive implants, stock abutments and stock copings (originally cleared per K163194) ●
- . GM (Grand Morse) Helix implants, stock abutments and stock copings (originally cleared per K163194)
The implants, abutments and copings of the Neodent Implant System are 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.
- Titamax WS implants, abutments and copings (originally cleared per K123022)
The implants, abutments and copings of the Neodent Implant System are 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. The Neodent Implant System may be used for single or multiple unit restorations. Multiple tooth applications may be rigidly splinted.
The Titamax WS implants are indicated for a delayed loading protocol.
- Facility implants, stock abutments and stock copings (originally cleared per K123022 and extended per K133696 and K150199)
The implants, abutments and copings of the Neodent Implant System are 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. The Neodent Implant System may be used for single or multiple unit restorations. Multiple tooth applications may be rigidly splinted.
The Facility implants of the Neodent Implant System are indicated for replacement of maxillary lateral incisors, mandibular incisors or retention of overdentures.
- Zygomatic implants, stock abutments and stock copings (originally cleared per K141777)
The Zygomatic implants, abutments and copings of the Neodent Implant System are 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 Zygomatic implants of the Neodent Implant System are indicated for surgical installation in the zygoma region in cases of severe jaw resorption in order to restore patient esthetics and chewing function. Zygomatic implants are recommended for the posterior (pre-molar/ molar) region, one implant on each side, with at least two standard dental implants in the anterior region to support a fixed restoration.
- CM (Cone Morse) Titanium Base Abutment component of two-piece patient-specific abutment (originally cleared per K150367 and extended per K153624)
- o GM (Grand Morse) Exact Titanium Base Abutment component of two-piece patient-specific abutment (originally cleared per K163194)
The implants, abutments and copings of the Neodent Implant System are 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 Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. The Titanium Base 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 are intended to be sent to Straumann for manufacture at a validated milling center.
- CM (Cone Morse) Titanium Base for CEREC Abutment component of two-piece patient-specific abutment (originally cleared per K160964)
The implants, abutments and copings of the Neodent Implant System are 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 Titanium Base for CEREC Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. They are 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 for CEREC Abutment 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.
- CM Preface Abutment component of patient-specific abutment (originally cleared per K150367)
The implants, abutments and copings of the Neodent Implant System are 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 Preface Abutment is a titanium abutment to be used in fabricating a full custom abutment placed onto Neodent dental implants to provide support for customized prosthetic restorations. The Preface Abutments is indicated for screw-retained single restorations or cement-retained single or multi-unit restorations.
All digitally designed restorations for use with the Neodent Preface Abutment are intended to be sent to Straumann for manufacture at a validated milling center.
- GM (Grand Morse) ProPEEK Abutments (originally cleared per K163194) ●
- CM (Cone Morse) ProPEEK Abutments (originally cleared per K170080)
The implants, abutments and copings of the Neodent Implant System are 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 Pro PEEK Abutment is indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months.
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Neodent Implant for Orthodontic Anchor (originally cleared per K102769) ●
The Neodent Implant for Orthodontic Anchor is a surgical device in the form of a temporary screw used as an aid in orthodontic movement procedures. -
. The Neodent Graft Screw (originally cleared per K103084)
The Neodent Graft Screw is an implantable device used for fixation of bone blocks for the regeneration of bone in the oral cavity. The product is intended for temporary use only.
Not Found
The provided text is a 510(k) Premarket Notification from the FDA regarding the MRI compatibility of various Neodent Implant System devices. It primarily focuses on defining the indications for use for different components of the implant system and does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment for an AI/Medical Device.
The document is a regulatory approval letter and descriptive indications for use, not a study report or technical performance assessment. Therefore, I cannot extract the requested information from this text.
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