(176 days)
SAVE GBR is a metal device intended for use with a dental implant to stabilize and support of bone graft in dentoalveolar bony defect sites.
The SAVE GBR consists of Healing Cap, Cover Cap and Spacer. The SAVE GBR are manufactured by Ti-6A1-4V ELI and used with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.
The subject device is compatible with the OssBuilder membrane cleared in K172354.
The dimension of the device is as below:
| No. | Product | Diameter | Length |
|---|---|---|---|
| 1 | Healing Cap | Ø4.5 and 5.5 | 6.0 and 7.0mm |
| 2 | Cover Cap | Ø4.5 | 4.0mm |
| 3 | Spacer | Ø4.5 | 7.2 and 8.2mm |
The healing cap and cover cap have same functions and uses but have different design and name. The SAVE GBR are removed from the patient after such time when sufficient bone regeneration is done.
I am sorry, but the provided text (K222451_Decision_Letter[1].pdf) does NOT contain information about acceptance criteria, device performance results, sample sizes for test and training sets, expert qualifications, ground truth establishment, or any details related to an AI/ML-driven medical device study.
The document is a 510(k) premarket notification letter from the FDA regarding a dental device called "SAVE GBR." This device is a metal component used with dental implants to stabilize and support bone grafts. The core of this FDA submission is to demonstrate substantial equivalence to already legally marketed predicate devices, not to present performance data from an AI/ML model.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details for an AI-driven device based on this input. The document focuses on material composition, dimensions, sterilization, shelf life, and intended use as compared to predicate devices, rather than AI performance metrics.
§ 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.)