Search Results

Dentalis Bio Solutions Implant System is used to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla. The device may be used equally well in a single-stage or two-stage surgical procedure. It is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.
The Dentalis Bio Solution implant with Narrow diameter Ø3.0 shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors situations.
Dentalis Bio Solution One Piece implants are specifically indicated for replacing maxillary lateral incisors and mandibular central and lateral incisors. They are used for immediate, non-occlusal provisionalization in single-tooth restorations

Not Found

I am sorry, but based on the provided document, there is no information available regarding the acceptance criteria or any study that proves the device meets specific acceptance criteria. This document is an FDA 510(k) clearance letter for the Dentalis Bio Solutions Implant System, which primarily confirms substantial equivalence to a predicate device.

The letter discusses:

• The device name and regulation details.
• The FDA's determination of substantial equivalence.
• General controls and other regulations the manufacturer must comply with.
• Indications for Use for the device.

It does not contain the specific details you requested, such as:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes, data provenance, or study design for performance evaluation.
3. Details about experts, ground truth establishment, or adjudication methods.
4. Information about MRMC studies or standalone algorithm performance.
5. Sample sizes or ground truth for training sets.

Therefore, I cannot fulfill your request for this specific information using the provided text.

Ask a specific question about this device