Search Results

Nobel Biocare's Molar Implants are endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. The Molar Implants are indicated for single or multiple unit restorations in the molar region. The Molar Implants can be used in splinted or non-splinted applications. The Molar Implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

Nobel Biocare's Molar Implants are threaded, root-form dental implants intended for use in the upper and lower jaw arches to support prosthetic devices, such as an artificial tooth, in order to restore esthetics and chewing function to partially or fully edentulous patients.

The Molar Implants are similar in design to the NobelSpeedy, Groovy, TiUnite, and NobelActive Internal Connection Implants. Like these implants, the Molar Implants are manufactured from commercially pure titanium. The implants utilize the TiUnite surface treatment and have the Groovy groove design feature.

The provided text describes a 510(k) summary for a dental implant, not a medical device with acceptance criteria for performance against a specific condition or disease, or a study to prove such performance. Therefore, I cannot extract the requested information like expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The submission focuses on establishing substantial equivalence to previously cleared devices based on material, design, and intended use. The "acceptance criteria" in this context would primarily relate to meeting regulatory standards and demonstrating similarity to predicate devices, rather than performance metrics for diagnostic or therapeutic accuracy.

Therefore, I am unable to provide a response to the prompt as medical devices without AI functionality and performance criteria are not included in this document.

Ask a specific question about this device