(168 days)
The CCM Abutment System is intended to replace missing teeth to restore chewing function. The CCM Abutment System can be placed in support of single or multiple-unit restorations including, cement retained, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.
CCM Abutment System is used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. CCM Abutment System consists of UCLA Abutment and titanium abutment screws. All subject abutments are intended to be cast at zero angulations and placed on dental implant bodies which do not require angle correction.
This document is a 510(k) Premarket Notification from the FDA, asserting "substantial equivalence" of the CCM Abutment System to previously marketed devices. These types of documents focus on comparing a new device to existing ones to demonstrate similar safety and effectiveness, rather than presenting a detailed study proving the new device meets specific, pre-defined quantitative acceptance criteria through clinical trials or standalone performance evaluations (especially relevant for AI/ML devices). This document describes a dental implant abutment system, which is a physical device, not an AI/ML-driven medical device. Therefore, the information typically requested for AI/ML device performance, such as sample sizes for test sets, data provenance, expert ground truth establishment, MRMC studies, or standalone algorithm performance, is not applicable to this document.
The document primarily relies on non-clinical data to demonstrate substantial equivalence, focusing on materials, design, indications for use, and manufacturing processes compared to predicate devices.
Here's the information that can be extracted relevant to acceptance and performance for this physical device, framed in the context of "substantial equivalence" rather than "meeting acceptance criteria" in the way an AI/ML device would:
Acceptance Criteria and Device Performance (for a physical dental abutment system)
The "acceptance criteria" here are implicitly tied to demonstrating substantial equivalence to legally marketed predicate devices. The performance is assessed through non-clinical testing and comparison of attributes.
Since this is a 510(k) for a physical dental abutment, the "acceptance criteria" are not quantitative performance metrics in the same way they would be for an AI/ML device. Instead, they are about demonstrating that the device is as safe and effective as predicate devices.
Table of "Acceptance Criteria" (Implicit for 510(k)) and Reported Device Performance:
| Feature/Test | Implicit "Acceptance Criteria" (Demonstrate equivalence to predicate) | Reported Device Performance / Justification |
|---|---|---|
| Intended Use | Same as predicate devices | The CCM Abutment System is intended to restore chewing function by replacing missing teeth, supporting single or multiple-unit restorations (cement-retained, screw-retained, fixed bridgework), and is for one/two-stage surgical procedures with delayed loading. This is stated to be the same as the primary predicate (K153350) and aligns with the general use of the reference predicates (K140806, K162099, K161244). |
| Technological Characteristics (Design, Dimension, Principle of Operation, Restoration Angulations) | Similar to predicate devices, with differences not raising new safety/effectiveness questions. | Similarities: Identical machining, manufacturing process, angulation (No Angle), and principle of operation (screw-retained/cement-retained depending on part). Differences: Slight differences in specific dimensions (diameters and lengths) of various abutment parts (UCLA Abutment, Burn out core cylinders/caps, Multi-unit CCM Cylinder) compared to predicates are noted but are considered not to raise new questions of safety or effectiveness. The device maintains "No Angle" for restoration angulations, consistent with predicates. |
| Material Composition | Equivalent to predicate devices, or justified if different. | Difference: Subject device uses Co-Cr-Mo Alloy and Poly Diacetate. The primary predicate (K153350) uses Titanium Alloy and Poly Diacetate. Justification: Reference predicate (K161244) uses Co-Cr-Mo Alloy, and biocompatibility testing was performed on the subject device to support the material difference. Galvanic reaction testing was also performed between CoCr alloy and Ti Gr.5. |
| Biocompatibility | Meets established standards (ISO 10993). | Biocompatibility tests performed according to ISO 10993-1, -3, -5, -10, -11. Results "met the criteria of the standards" and "demonstrates that the subject device is biocompatible and substantial equivalence with the predicate device, K161244." |
| Sterilization | Meets established standards (ISO 17665, ANSI/AAMI ST79). | End User Steam Sterilization Test referenced from predicate K140806. Justified because "product category, material, manufacturing process, facility, and packaging is the exactly the same as the predicate." |
| Galvanic Reaction | Acceptable corrosion potential between alloys. | Testing performed for CoCr alloy and Ti Gr.5 as per "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant abutments." Assessed corrosion potential and couple potential. "Results...met the criteria of the standards." |
| Performance Validation (General Statement) | Supposed to performance and product validations prior to release. | "The subject device has been supposed to performance and product validations prior to release." (General statement, specific test data or detailed results not provided in this summary.) |
Study Details (as applicable to a physical device 510(k) submission):
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Sample size used for the test set and the data provenance:
- Not applicable in the context of an AI/ML device. This document does not refer to a "test set" of patient data for algorithm evaluation.
- For the non-clinical tests (biocompatibility, galvanic reaction), the "sample size" would refer to the number of physical device units tested according to the respective ISO/ASTM standards. These details are not provided in this summary but would be part of the full submission. The provenance is internal lab testing for a new device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in this context is implicitly established by the standards themselves (e.g., ISO 10993 specifications for biocompatibility) and engineering principles for mechanical functionality. Human expert consensus on a test set of images or data is not a component of this submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This refers to a process for resolving discrepancies in expert labeling or diagnoses, which is not relevant for this physical device testing.
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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 a study design for evaluating diagnostic AI, not a physical dental device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This pertains to AI/ML software.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" is defined by the specific criteria and methodologies outlined in the referenced international standards (e.g., ISO 10993 for biocompatibility, ISO 17665 for sterilization). For galvanic reaction, it's based on "corrosion potential" and "couple potential" as assessed per FDA guidance for dental implants.
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The sample size for the training set:
- Not applicable. This is for AI/ML model development.
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How the ground truth for the training set was established:
- Not applicable. This is for AI/ML model development.
In summary, this document is a regulatory communication for a Class II physical medical device, not an AI/ML-driven diagnostic tool. As such, the requested details related to AI/ML study design and performance criteria are not present because they are not relevant to the type of device and submission being reviewed. The "study" proving the device meets "acceptance criteria" is the set of non-clinical bench tests and comparisons performed against established predicate devices and international standards, demonstrating "substantial equivalence."
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)