(296 days)
The Pro PEEK Abutments are indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months. They can be used in one or two stage procedures and also immediate load when there is good primary stability.
CM Pro PEEK abutments are temporary intermediary prosthetic components to be installed onto CM Implants to support the provisional prosthesis up to 6 months. They are composed of a customizable cylindrical body with an internal channel for the screw access and of a base for anti-rotational implant connection. The customizable portion is manufactured in PEEK (high performance polymer – specific for dental use) and the implant-to-abutment interface is made of titanium alloy. They have a coupled screw for fixing them to the Implant. They present a hexagonal indexing at the apical end of the Morse taper connection to provide anti-rotational feature to the implant-to-abutment connection, and facilitates proper alignment of the prosthesis to the implant. They are available in diameters of 4.5 and 6.0 mm and in lengths of 0.8, 1.5, 2.5, 3.5, 4.5 and 5.5 mm. The customization of the PEEK chimney must be done into the mouth of patient or chairside. Chairside customization means that the device preparation must be done in a controlled environment in the operating room, in the context of the prosthetic placement, in a surgical site's aseptic environment using sterilized tools. The dentist can wear the PEEK chimney with the aid of suitable techniques, high speed handpiece and cooling, according to the patient interocclusal space, respecting the minimum of 5mm of height. No customization is allowed for the diameter/ wall thickness of the abutment, as well as no angulation. No CAD/CAM design and fabrication is allowed for the CM Pro PEEK Abutments. Only hand-milling may be used for abutment modification. The CM Pro PEEK abutments can be used before the installation of the final prosthesis to maintain, stabilize and shape the soft tissue (gum) during the healing phase.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | No extracts of leachable substances of concern were identified. No cytotoxicity response was observed. (Assessed according to ISO 10993-1, ISO 10993-5, ISO 10993-18) |
| Mechanical Strength (Dynamic Fatigue) | Strength demonstrated through fatigue testing. (Performed according to ISO 14801 and FDA Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments) |
| Sterilization Assurance Level (SAL) | SAL of 10⁻⁶ achieved. (Validated by bioburden method, according to ISO 11135) |
| Ethylene Oxide (EO) Sterilization Residuals | Less than the maximum allowable limits. (Verified according to ISO 10993-7) |
| Sterile Barrier Shelf Life | 2 years. (Determined through real-time and accelerated aging protocol, according to ASTM F1980. Tested for sterility, thermal seal integrity, and tensile strength of thermal seal according to ISO 11737, US Pharmacopeia, ASTM E499/E499M, ASTM F1929, and ASTM F88/F88M) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the "test set" in terms of number of devices for biocompatibility, mechanical, or sterilization testing. It mentions "samples" were submitted for testing.
The data provenance is from laboratory testing performed by or for JJGC Indústria e Comércio de Materiais Dentários SA, a company based in Curitiba, Parana, BRAZIL. The clinical data was not submitted or relied upon, so the testing is likely retrospective in the sense that it's laboratory data, not data gathered from human trials.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable as the studies conducted are laboratory-based performance tests (biocompatibility, mechanical, sterilization validation) and do not involve human interpretation or subjective assessment that would require expert ground truth establishment in the way it's typically understood for AI/diagnostic devices. The acceptance criteria are based on established international standards (ISO, ASTM) and FDA guidance documents.
4. Adjudication Method for the Test Set
This is not applicable for the type of laboratory performance studies described. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation of medical images or clinical outcomes, which did not occur here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study involved laboratory performance testing of the device itself, not a comparison of human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
No, a standalone algorithm performance study was not done. This submission is for a physical medical device (dental abutment), not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests consists of:
- Compliance with international standards: ISO 10993 series for biocompatibility, ISO 14801 and FDA Guidance for Mechanical Strength, ISO 11135 and ISO 10993-7 for Sterilization, and ASTM F1980, ISO 11737, US Pharmacopeia, ASTM E499/E499M, ASTM F1929, and ASTM F88/F88M for Shelf Life.
- Predicate device characteristics: The subject device's performance is compared against the established performance and characteristics of legally marketed predicate devices to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical dental abutment, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for a physical device.
§ 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.)