(89 days)
HU/HS/HG Prosthetic System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
The HU/HS/HG Prosthetic System is device made of titanium, titanium alloy, POM and PC intended for use as an aid in prosthetic restoration. It consists of Abutment, Protect Cap and Abutment Screw. Its surfaces are partially Tin coated and uncoated.
The provided text describes a 510(k) premarket notification for the OSSTEM HU/HS/HG Prosthetic System, a dental device. This type of submission relies on demonstrating substantial equivalence to existing legally marketed devices (predicates) rather than providing new clinical study data with specific acceptance criteria and performance metrics.
Therefore, the document does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for AI/CADe devices.
Instead, the document focuses on:
- Device Description: The HU/HS/HG Prosthetic System is made of titanium, titanium alloy, POM, and PC, intended for prosthetic restoration with dental implants.
- Predicate Devices: The device is compared to several existing OSSTEM Implant Co., Ltd. systems (US System K062030, SS System K062051, GS System K063861, US/SS/GS System K073247).
- Claim of Substantial Equivalence: The manufacturer asserts that the new system is substantially equivalent in design, function, intended use, materials, and performance characteristics to the predicate devices.
- Safety and Performance Validation: It mentions that safety tests, including biocompatibility, were performed to ensure compliance with international and US regulations.
There is no discussion of an AI/CADe device, performance metrics like sensitivity/specificity, or a study to "prove the device meets acceptance criteria" in the way one would for diagnostic software. This is a clearance for a physical dental prosthesis system, not an AI-powered diagnostic tool.
§ 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.)