(294 days)
The CreoDent Solidex® Customized Abutment and Screw is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely edentulous. The device can be used for single or multiple-unit restorations. The prosthesis can be cemented, or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant. CreoDent Solidex Customized Abutments and Screws to be compatible with the Implant Direct InterActive/Swish Active 3.0mm implants are only indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.
The Solidex® Customized Abutment and Screw is Ti-6A1-4V Eli titanium alloy meets ASTM F-136 standard and is designed to be screw retained for use with endosseous dental implants to provide support for a prosthetic restoration. These abutments are indicated for cement or screw retained restorations. Solidex® Customized Abutment and Screw are compatible with:
| Manufacturer | Implant Line | Platform
Diameter
(mm) | Implant
Body
Diameter
(mm) | Max
Diameter | Wall
Thickness
(mm) | Height
Min/Max
(mm) | Post
Height
Min/Max
(mm) | Collar
Height
Min/Max
(mm) | Angulation
Min/Max
(Degress) |
|-------------------------------|--------------|------------------------------|-------------------------------------|--------------------------------|---------------------------|---------------------------|-----------------------------------|-------------------------------------|------------------------------------|
| Neodent
Implant
Systems | GM Line | 3.5/3.75 | 3.5/3.75 | 5mm
from
Implant
Axis | .68 | 5 - 10 | 4 - 9 | 1 - 5 | 0 - 20 |
| Manufacturer | Implant Line | Platform
Diameter
(mm) | Implant
Body
Diameter
(mm) | Max
Diameter | Wall
Thickness
(mm) | Height
Min/Max
(mm) | Post
Height
Min/Max
(mm) | Collar
Height
Min/Max
(mm) | Angulation
Min/Max
(Degress) |
| Implant Direct
Sybron
Manufacturing
LLC | 2014
InterActive/SwishActive
System | 3.0 | 3.0 | 5mm
from
Implant
Axis | .68 | 5 - 10 | 4 - 9 | 1 - 5 | 0 - 20 |
The design of subject device is customized to the requirements of each patient as may be specified by the prescribing dentist. Customization is limited by the minimum dimensions for wall thickness, diameter, height, collar height and angulation.
This document, K220390, is a 510(k) Premarket Notification of intent to market the CreoDent Solidex® Customized Abutment and Screw. The document focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than detailing a study that proves the device meets specific acceptance criteria for a novel AI/software component.
Therefore, many of the requested elements for an AI/software study (e.g., sample size for test/training sets, ground truth establishment for AI, MRMC studies, effect size, etc.) are not applicable to this specific document as it is for a physical medical device (dental abutment and screw) and not an AI-powered device.
However, I can extract the information relevant to the device's performance demonstration for its intended function (mechanical strength and biocompatibility), which serves as its "acceptance criteria" for safety and effectiveness in the context of this 510(k) submission.
Here's a breakdown based on the provided document and the non-applicability of AI/software-specific questions:
1. A table of acceptance criteria and the reported device performance
For a physical device like a dental abutment, acceptance criteria primarily revolve around meeting established mechanical and biological safety standards for its intended use.
| Acceptance Criteria (Proxy) | Related Test / Demonstrated Performance |
|---|---|
| Mechanical Strength & Durability | Static/Fatigue testing in accordance with ISO 14801:2007E (Dentistry-Implants-Dynamic fatigue test for endosseous dental implants) |
| Specific Performance | Demonstrated "sufficient mechanical strength for their intended clinical application" (based on worst-case scenario for screw connection platform). |
| Dimensional Accuracy & Compatibility | Reverse engineering dimensional analysis conducted using OEM implant bodies, OEM abutment screws. |
| Specific Performance | Demonstrated compatibility with specified implant systems (Neodent GM Line, Implant Direct InterActive/SwishActive System). |
| Biocompatibility / Cytotoxicity | Evaluation in accordance with ISO 10993-5 (Biological evaluation of medical devices - Part 5: Test for in vitro cytotoxicity). |
| Specific Performance | "No evidence of causing cell lysis or toxicity." |
| Sterilization Efficacy | Sterilization validation according to ISO 17665-1. |
| Specific Performance | Performance confirmed (detail not specified beyond "performed"). |
| MRI Safety | Non-clinical worst-case MRI review performed using scientific rationale and published literature (e.g., Woods et al.). |
| Specific Performance | Rationale addressed parameters for magnetically induced displacement force and torque based on FDA guidance. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for each test, but standard for mechanical and biocompatibility testing of medical devices involves a sufficient number of samples to ensure statistical validity and representativeness (e.g., typically N=5 or N=10 for fatigue testing, multiple test specimens for biocompatibility). The document refers to "worst-case scenario" which implies targeted testing.
- Data Provenance: The testing was non-clinical (laboratory-based). "T.Strong INC obtains titanium alloy and c.p. titanium from US suppliers." CreoDent Prosthetics finalizes the abutment device at their manufacturing facility in New York. The testing would have been conducted by or for the manufacturer or a contracted lab.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a physical device, and the "ground truth" is established by adherence to recognized international standards (ISO, ASTM) for mechanical and biological properties, which are defined by material specifications and test methods, not expert consensus readouts.
4. Adjudication method for the test set
- Not Applicable. See point 3. Mechanical and biocompatibility tests are pass/fail based on objective measurements against predefined limits in 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 a physical device, not an AI-powered diagnostic or assistive tool. MRMC studies are for evaluating human performance (e.g., clinicians reading images) with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this physical device is defined by established international standards (ISO, ASTM) and material specifications for mechanical properties (e.g., fatigue life, strength) and biocompatibility (e.g., absence of cytotoxicity). It's objective measurement against these standards, not a subjective interpretation.
8. The sample size for the training set
- Not Applicable. This is a physical device, not a machine learning model. There is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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.)