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510(k) Data Aggregation
(96 days)
MIS Ti-base abutment
MIS Ti-base abutment is a titanium base placed onto MIS dental implants to provide support for customized cement-retained or screw retained single or multiple-unit restorations. It is used with a digitally designed mesostructure. MIS Ti-base and the mesostructure make up a two- piece abutment used in conjunction with MIS dental implants, to be placed in the upper or lower jaw arches, in order to restore masticatory function.
Narrow platform Ti-bases are indicated for use only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws.
MIS short implants are to be used only with straight abutments. Mesostructures for use with the MIS Tibase abutment are to be made from inCoris ZI, IPS e.max® CAD Abutment or VITA ENAMIC® (IS), designed and manufactured using Sirona CEREC SW version 4.6.1 software.
MIS Ti-base abutments are intended for use with the following MIS implants:
- C1 conical connection implant system
- V3 conical connection implant system
- SEVEN internal hex implant system
- M4 internal hex implant system
- Lance+ internal hex implant system
The subject MIS Ti-base abutments are endosseous dental implant abutments intended to be connected to MIS dental implants and used to support CAD/CAM customized cement-retained or screw retained single or multiple-unit restorations.
MIS Ti-base abutments consist of a titanium base and a prosthetic screw, both made of TI-6AI-4V ELI complying with ASTM F136. The prosthetic screw tightens the finished CAD/CAM abutment to the dental implant.
MIS Ti-base abutments are the bottom-half/base of a two-piece custom ceramic-titanium abutment consisting of a ceramic coping/mesostructure and a titanium base.
The top-half custom ceramic coping/mesostructure or crown is intended to be fabricated from Sirona inCoris ZI zirconium oxide ceramic block, IPS e.max® CAD ceramic block, or from IPS e.max® CAD ceramic block or VITA ENAMIC® (IS) ceramic block and designed and milled using Sirona chairside Dental CAD/CAM System, with software version: CEREC SW version 4.6.1. The mesostructure design will be subject to the Sirona system controls, such as: A maximum angulation of 20° and minimum wall thickness of 0.5mm for inCoris ZI and e.max materials and 0.8mm for VITA ENAMIC material.
It is not permitted to reduce the Ti-base's diameter, shorten the Ti-base or modify its implant-abutment connection and emergence profile in any way.
The subject, pre-fabricated titanium base abutment is designed with interface compatibility to specific MIS dental implant systems. The subject MIS Ti-base abutments are MIS connection and internal hex connection Ti-base abutments, and their connection is compatible with MIS conical connection C1 and V3 implants, and MIS SEVEN, M4 and Lance+ internal hex implants, which are not subject to this submission and were previously cleared.
This document describes a 510(k) premarket notification for the MIS Ti-base abutment. This is an FDA submission for devices that are "substantially equivalent" to predicate devices, meaning they have the same intended use and similar technological characteristics. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are typically demonstrating this substantial equivalence through non-clinical performance data, rather than a clinical trial with specific performance metrics like sensitivity or specificity for an AI algorithm.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission for a physical medical device (dental abutment) and not an AI algorithm, the "acceptance criteria" are related to demonstrating that the device performs as safely and effectively as a legally marketed predicate device. The performance is assessed through non-clinical testing against established standards.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (Summary of Non-clinical Testing) |
|---|---|
| Biocompatibility | The subject device is manufactured using identical methods, facility, and raw material as the predicate (K191152). Patient contact duration and type are the same. IPS e.max® and VITA ENAMIC® (IS) mesostructure materials are cleared under K191382 and K153645 respectively, and no modifications to these materials are included. No new biocompatibility testing was required. |
| Fatigue Testing (Mechanical Performance) | Withstand 2,000,000 cycles without failure at a substantially equivalent load to the cited predicates, as per ISO 14801:2016. Worst-case abutments (narrowest, 20° mesostructure, various materials) were tested. |
| Sterilization Testing | Validated steam sterilization parameters (gravity displacement and pre-vacuum) for inCoris ZI mesostructure according to ANSI/AAMI/ISO 17665-1:2006 and ANSI/AAMI/ISO 17665-2:2009. For IPS e.max and VITA ENAMIC (IS) mesostructures, recommended parameters are based on predicate clearances K191382 and K153645. |
| Software Verification and Validation (CAD/CAM Integration) | Software verification and validation testing for the abutment design library demonstrated that restrictions prevent design of the mesostructure component outside of design limitations. The encrypted design library was validated to ensure established limitations are locked and cannot be modified. (For CEREC SW version 4.6.1). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a "test set" in the context of clinical data for AI. For the non-clinical fatigue testing, "worst case abutments" were chosen. The exact number of samples tested for each worst-case configuration (e.g., number of narrowest abutments, number of specific mesostructures) is not explicitly stated but implied to be sufficient for ISO 14801:2016 compliance.
- Data Provenance: Not applicable in the context of clinical or retrospective data for an AI algorithm. The performance data comes from laboratory non-clinical tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable as this is a non-clinical device submission for a physical component, not an AI algorithm requiring expert ground truth for interpretation.
4. Adjudication Method for the Test Set
- Not applicable for a non-clinical device submission.
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
- Not applicable. This is not an AI-assisted diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical dental abutment. The software mentioned (CEREC SW version 4.6.1) is for design and milling, not a standalone AI diagnostic algorithm.
7. The Type of Ground Truth Used
- For fatigue testing, the "ground truth" is defined by the mechanical strength and durability requirements of the ISO 14801:2016 standard, ensuring the device can withstand chewing forces.
- For biocompatibility, the "ground truth" is adherence to ISO 10993-1 and prior clearances of materials used.
- For sterilization, the "ground truth" is effective sterilization as demonstrated by ANSI/AAMI/ISO 17665 standards.
- For software verification, the "ground truth" is the established design limitations and the software's ability to enforce them.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI algorithm that requires a training set. The software mentioned (CEREC SW) is a CAD/CAM design software, not a machine learning model developed with a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable as there is no training set for an AI algorithm.
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(432 days)
MIS Ti-base Abutment
MIS Ti-base abutment is a titanium base placed onto MIS dental implants to provide support for customized cement-retained or screw retained single or multiple-unit restorations.
It is used with a digitally designed mesostructure. MIS Ti-base and the mesostructure make up a two-piece abutment used in conjunction with MIS dental implants, to be placed in the upper or lower jaw arches, in order to restore masticatory function.
Narrow platform Ti-bases are indicated for use only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws.
MIS short implants are to be used only with straight abutments.
Mesostructures for use with the MIS Ti-base abutment are to be made from inCoris ZI, designed and manufactured using Sirona CEREC SW version 4.6.1 Software.
MIS Ti-base abutments are intended for use with the following MIS implants:
C1 conical connection implant system. V3 conical connection implant system. SEVEN internal hex implant system. M4 internal hex implant system and Lance+ internal hex implant system.
The subject MIS Ti-base abutments are endosseous dental implant abutments intended to be connected to MIS dental implants and used to support CAD/CAM customized cement-retained or screw retained single or multiple-unit restorations.
MIS Ti-base abutments consist of a titanium base and a prosthetic screw, both made of TI-6AI-4V ELI complying with ASTM F136. The prosthetic screw tightens the finished CAD/CAM abutment to the dental implant.
MIS Ti-base abutments are the bottom-half/base of a two-piece custom zirconia-titanium abutment consisting of a zirconium coping/mesostructure and a titanium base.
The top-half custom zirconia coping/mesostructure or crown is intended to be fabricated from Sirona inCoris ZI zirconium oxide ceramic block and designed and milled using Sirona chairside Dental CAD/CAM System, with software version: CEREC SW version 4.6.1. The mesostructure design will be subject to the Sirona system controls, such as: A maximum angulation of 20° and minimum wall thickness of 0.5mm. The InCoris Zi mesostructure is to be cemented to the subject MIS Ti-base abutments using PANAVIA F 2.0 dental cement in order to complete the two-piece, CAD/CAM abutment.
lt is not permitted to reduce the Ti-base's diameter, shorten the Ti-base or modify its implant-abutment connection and emergence profile in any way.
The subject pre-fabricated titanium base abutment is designed with interface compatibility to specific MIS dental implant systems. The subject MIS Ti-base abutments are MIS conical connection and internal hex connection Ti-base abutments, and their connection is compatible with MIS conical connection C1 and V3 implants, and MIS SEVEN, M4 and Lance+ internal hex implants, which are not subject to this submission and were previously cleared.
Here's a breakdown of the requested information based on the provided FDA 510(k) document for the MIS Ti-base Abutment.
Important Note: This document describes a dental abutment, not an AI/ML device. Therefore, many of the requested fields regarding AI/ML-specific study aspects (e.g., sample size for training set, number of experts for ground truth, MRMC study, standalone algorithm performance) are not applicable to this type of medical device submission. The FDA 510(k) process for a device like this focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance testing.
Device Name: MIS Ti-base Abutment
Regulation Number: 21 CFR 872.3630
Regulation Name: Endosseous Dental Implant Abutment
Regulatory Class: Class II
Product Code: NHA
1. Table of Acceptance Criteria and Reported Device Performance
For non-AI/ML medical devices like this, "acceptance criteria" are tied to demonstrating substantial equivalence to a predicate device, often through mechanical and material testing against established standards. The performance is assessed against these standards and comparative data from the predicate.
| Acceptance Criteria Category | Specific Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Material Compatibility | Made of TI-6Al-4V ELI complying with ASTM F136. | The device is made of TI-6Al-4V ELI complying with ASTM F136. |
| Biocompatibility | Meet biocompatibility requirements for patient contact duration and type. | Biocompatibility testing was not required for the subject device. It is manufactured using identical methods, facility, and raw material as a previously cleared reference device (K163349) with the same patient contact. The mesostructure material (InCoris ZI) is also previously cleared (K181520). |
| Dynamic Fatigue | Withstand 2,000,000 cycles without failure at a substantially equivalent load to cited predicates, adhering to ISO 14801:2016. | The worst-case abutments (narrowest from narrow and standard platforms, with 20° mesostructure) withstood 2,000,000 cycles without failure at a substantially equivalent load to predicates. The standard platform worst case also supported wide platform abutments. The results support substantial equivalence. |
| Sterilization Efficacy | Validate steam sterilization parameters for both gravity displacement and pre-vacuum methods, according to ANSI/AAMI/ISO 17665-1:2006 and ANSI/AAMI/ISO 17665-2:2009. | Sterilization parameters were validated for both gravity displacement and pre-vacuum steam sterilization methods according to the specified ISO standards. |
| Software Verification & Validation | Demonstrate that the abutment design library prevents mesostructure component design outside of limitations and that established design limitations are locked. | Software verification and validation testing was provided for the abutment design library to demonstrate use with CEREC SW version 4.6.1. It demonstrated restrictions preventing design outside limitations and that design limitations were locked. |
| Mechanical Design Integrity | Not permitted to reduce Ti-base's diameter, shorten the Ti-base, or modify its implant-abutment connection or emergence profile. | This is a design specification, adherence to which is asserted by the manufacturer. The document doesn't detail performance testing specifically verifying "non-modification" in the field, but rather the manufacturer's control over the design. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- For Fatigue Testing (ISO 14801:2016), samples were tested. While a specific number isn't explicitly stated on the provided pages, ISO 14801 typically requires a sufficient number of samples (often 5-10 per test group) to achieve statistically meaningful results for fatigue curves. The document refers to testing "worst case abutments" from both narrow and standard platforms.
- For Sterilization Testing, an unspecified number of representative samples would have been used for validation.
- For Software Verification & Validation, the "test set" would be various design scenarios and inputs used to confirm software functionality and adherence to design constraints. The specific "sample size" of test cases is not quantified here.
- Data Provenance: The studies were non-clinical performance tests conducted by MIS Implants Technologies (manufacturer). The location of testing is not specified, but the manufacturer (Dentsply Sirona / MIS Implants Technologies Ltd.) is located in the USA (York, Pennsylvania) and Israel, respectively. These are prospective tests performed specifically for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- N/A (Not Applicable for this device type). Ground truth based on expert consensus is typically relevant for AI/ML diagnostic or prognostic devices. For a dental implant abutment, "ground truth" is established by adherence to engineering standards, material specifications, and mechanical performance limits. The "experts" involved would be engineers and quality control personnel responsible for developing and conducting the tests, interpreting standard requirements, and designing robust products. Their qualifications would be in relevant engineering, materials science, and quality assurance fields.
4. Adjudication Method for the Test Set
- N/A (Not Applicable for this device type). Adjudication methods like 2+1 or 3+1 are used in clinical studies, especially for AI/ML devices, where human readers (often physicians) independently evaluate medical images or data, and a tie-breaking or consensus process is needed. For mechanical and software performance testing, adjudication is based on objective measurements and established pass/fail criteria from international standards.
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. This is not an AI/ML device, so an MRMC study comparing human reader performance with and without AI assistance was not conducted and is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- N/A. This is not an AI/ML algorithm. Its "performance" is mechanical and procedural, not algorithmic. The software component (CEREC SW) is for design and manufacturing, not for automatic diagnosis or interpretation.
7. The Type of Ground Truth Used
- For this device, the "ground truth" is established by:
- Engineering Standards: Adherence to established international voluntary consensus standards (e.g., ISO 14801:2016 for fatigue, ANSI/AAMI/ISO 17665 for sterilization).
- Material Specifications: Compliance with material standards (e.g., ASTM F136 for TI-6Al-4V ELI).
- Validated Design & Manufacturing Parameters: Verification that the CAD/CAM software maintains design limitations and that the manufacturing process yields correct physical properties.
- Predicate Device Performance: Comparative performance data against the legally marketed predicate devices serves as a benchmark for substantial equivalence.
8. The Sample Size for the Training Set
- N/A. This is not an AI/ML device, so there is no "training set." The development process relies on engineering design, material science, and established manufacturing practices, not machine learning.
9. How the Ground Truth for the Training Set was Established
- N/A. As there is no training set for an AI/ML model, this question is not applicable.
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