(254 days)
Biodenta Dental Implant System Abutments are intended for terminal or intermediate abutment support for fixed or removable crown or bridgework.
The Biodenta Dental Implant System Abutments is an extension and compatible to the Biodenta Dental Implant System Bone Level (K111003) which is an integrated system of endosseous dental implants, abutments and prosthetic parts and related surgical instruments.
The Biodenta Dental Implant System Abutments includes 3 abutment types:
Temporary PEEK abutments are manufactured of biocompatible PEEK plastic and used for temporary restorations for 180 days or less. They are attached to the dental implant using an abutment screw made of titanium alloy.
Swift Abutments are manufactured of biocompatible Titanium Alloy. The Abutments are attached to the implant by screwing them directly to the implant with the integrated screw thread. The Swift Abutments are designed in order that crowns and bridges can be attached by cement retention.
Sleeve Abutments are manufactured of biocompatible Titanium Alloy. The Abutments are attached to the implant by screwing them directly to the implant with the integrated screw thread. The Sleeve abutments are designed in order that bridges can be attached by screw retention.
All Abutments are straight abutments.
The provided document is a 510(k) Summary for the Biodenta Dental Implant System Abutments. This type of document is for regulatory clearance of medical devices and focuses on demonstrating substantial equivalence to predicate devices, rather than detailed performance studies with acceptance criteria and statistical analysis as is common for AI/ML-based medical devices or more complex devices requiring clinical trials.
Therefore, the input document does not contain the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, or MRMC studies, standalone performance, or training/test set specifics.
The document primarily states:
-
Non-clinical Testing Data:
- No further fatigue testing was performed, referencing a guidance document for "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseus Dental Implant Abutment." (This implies the device is presumed to meet performance standards if it meets the guidance's conditions, rather than requiring specific new fatigue tests).
- A sterilization validation was carried out according to ISO 14937:2009.
- Biocompatible raw materials were used, and chemical cleanness by XPS analysis and leachable cytotoxic substances (ISO 10993-5:2009) were investigated.
- A risk analysis was carried out, referencing the same guidance document.
-
Equivalence to marketed device: The report claims "substantial equivalence... in intended use, material composition, fundamental scientific technology, principles of operation, and basic design" to predicate devices. This is the core of a 510(k) submission, where direct performance metrics against acceptance criteria are often replaced by comparisons to devices already on the market.
Based on the provided text, I cannot complete the requested tables and information as it is not present in the document. The document describes a regulatory submission for a dental implant abutment, which relies on demonstrating equivalence to predicate devices and adherence to established standards for materials and sterilization, rather than performance studies with quantified acceptance criteria as typically seen for novel diagnostic or AI-driven devices.
§ 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.)