(98 days)
Dentis I-FIX Abutment is intended for use as an aid in prosthetic rehabilitation.
Dentis I-FIX Abutment consists of I-FIX Angled Type Fixture Healing Abutment, I-FIX Angled Type Fixture Healing Abutment Screw, and I-FIX Abutment Screw.
I-FIX Angled Type Fixture Healing Abutment and I-FIX Angled Type Fixture Healing Abutment Screw are compatible with following Implant Systems:
Proprietary Name: I-FIX System (Angled Type Fixture)
Compatible Implants (K number): K083586
Implant diameter size: Ø 2.0, 2.5, 3.0 mm
Implant length: 10~16 mm
I-FIX Abutment Screw is only used with I-FIX Cemented Abutment and I-FIX Free Abutment cleared in K083586.
The dimensions of abutments are as following:
- I-FIX Angled Type Fixture Healing Abutment: (D) 4.03 X (L) 3.2, 4, 5 and 7 mm, Angulation 0°
- I-FIX Angled Type Fixture Healing Abutment Screw: (D) 2.15 X (L) 4.0, 4.8, 6.1 and 8.0 mm, Angulation 0°
- I-FIX Abutment Screw: (D) 2.15 X (L) 4.7 mm, Angulation 0°
Tolerance of dimension for Abutments shall be within ± 1% range.
The Abutments have below featured:
- I-FIX Angled Type Fixture Healing Abutment: Uses - The healing Abutment is used for protecting inner hole of fixture and adjusting the appropriate height during the healing period. Surface - Non. Materials - Titanium Grade 4.
- I-FIX Angled Type Fixture Healing Abutment Screw: Uses - The healing Abutment is used for protecting inner hole of fixture and adjusting the appropriate height during the healing period. Surface - Non. Materials - Ti-6Al-4V ELI.
- I-FIX Abutment Screw: Uses - I-FIX Abutment screw is used with the previously cleared devices, K083586 such as I-FIX Cemented and Free Abutment for connecting with fixture. Surface - Non. Materials - Ti-6Al-4V ELI.
I-Fix Angled Type Fixture Healing Abutment and I-FIX Angled Type Fixture Healing Abutment Screw are packaged as a set and provided sterilized. I-FIX Abutment Screw is provided non-sterilized.
Materials:
- I-FIX Angled Type Fixture Healing Abutment is fabricated from pure titanium (Conforming to ASTM Standard F67)
- I-FIX Angled Type Fixture Healing Abutment Screw and I-FIX Abutment Screw are fabricated from Ti-6Al-4V ELI (Conforming to ASTM Standard F136)
This FDA 510(k) submission for the Dentis I-FIX Abutment indicates that the device is substantially equivalent to predicate devices, meaning it does not require a new study to prove its effectiveness or safety. Instead, the submission relies on existing data from predicate devices and non-clinical testing. Therefore, there is no specific de novo study described for this device with acceptance criteria and reported device performance in the traditional sense of a clinical trial.
However, I can extract the acceptance criteria that were met through non-clinical testing by referring to the standards and guidance mentioned.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with quantitative acceptance criteria and specific numerical reported device performance for the Dentis I-FIX Abutment as one would expect from a de novo clinical study. Instead, it states that various non-clinical tests were performed and that "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device."
Here are the types of criteria that were met, based on the standards cited:
| Acceptance Criteria Type | Reported Device Performance |
|---|---|
| Material Conformance | Meets ASTM Standard F67 (for CP Titanium Gr4) and ASTM Standard F136 (for Ti-6Al-4V ELI) |
| Sterilization Validation | Meets ISO 11137-1, 2, 3 (for gamma sterilization) and ANSI/AAMI ST79, ISO 17665-1, -2, ISO 11737-1, -2, ISO 11138-1 (for end-user sterilization) |
| Shelf Life | Meets ASTM F1980 |
| Biocompatibility | Meets ISO 10993-1:2009 |
| Tolerance of Dimension | Within ± 1% range (as stated on page 4) |
| MRI Safety | Scientific rationale and published literature (e.g., Woods, Terry O., et al., 2019) used to assess magnetically induced displacement force and torque, meeting parameters per FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for the non-clinical tests performed. These tests are typically conducted on a limited number of device samples in a laboratory setting. The data provenance is also unspecified beyond the general reference to "Non-Clinical Test Data" and the identification of Dentis Co., Ltd. as the manufacturer in Korea.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as the submission relies on non-clinical engineering and materials testing, not a study requiring expert clinical assessment for ground truth. The "ground truth" here is objective measurement against established engineering and biocompatibility standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable as there was no clinical study with a test set requiring adjudication of findings.
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 section is not applicable. The Dentis I-FIX Abutment is a physical dental device, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. The device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" used for non-clinical testing was based on:
- Established international and national standards (e.g., ISO, ASTM, ANSI/AAMI).
- Material specifications (e.g., ASTM F67, ASTM F136).
- Engineering specifications (e.g., dimensional tolerances).
8. The sample size for the training set
This section is not applicable. There was no "training set" in the context of machine learning or AI development for this physical device. The device design and manufacturing processes are based on established engineering principles and materials science.
9. How the ground truth for the training set was established
This section is not applicable for the reasons stated in 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.)