(79 days)
The Intra-Lock Mini Drive Lock™ Implant System Prosthetics have been designed to restore partially or fully edentulous patients. The abutments have been designed to be used in either the mandible or maxilla and to support removable or fixed prosthesis.
The Intra-Lock Mini Drive-Lock™ Dental Implant System Prosthetics consist of straight and angled cement retained abutments in various sizes. There are also provisions on the implants for overdenture retention abutment allowing for tissue born or combination tissue and tooth born removable prosthetic appliances. The prosthetics allow for full arch restorations, for either fixed or removable prosthetic appliances. The abutment raw materials consist of Titanium Alloy for Surgical Implant Applications (as per ASTM F 136) Standard Specification for Wrought Titanium-6Aluminium-4Vanadium ELI (Extra Low Interstitial) Alloy. The abutment components are non sterile packaged.
The provided text describes the regulatory clearance of a dental implant system and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through a clinical or technical study setup.
The submission is an "Abbreviated 510(k)," meaning it relies on demonstrating conformity with FDA guidance documents and substantial equivalence to predicate devices rather than presenting new performance data from a dedicated study.
Therefore, I cannot fulfill the request for information regarding:
- A table of acceptance criteria and reported device performance: This type of data is not present in the provided document.
- Sample size used for the test set and data provenance: No test set is described.
- Number of experts used to establish ground truth and qualifications: No ground truth establishment process is described.
- Adjudication method: Not applicable as no test set or ground truth establishment is described.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned.
- Standalone (algorithm only) performance: Not applicable as this is a physical dental device, not an algorithm.
- Type of ground truth used: Not applicable as no ground truth is established.
- Sample size for the training set: Not applicable as this is a physical device, not a machine learning algorithm.
- How the ground truth for the training set was established: Not applicable.
The document focuses on the regulatory process for enabling the marketing of the device based on its substantial equivalence to previously approved devices and adherence to relevant guidance documents.
§ 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.)