(90 days)
ARUM Dentistry's Pre-Milled Blank abutments are intended for attachment to dental implants in order to provide support for customized prosthetic restorations. Pre-Milled Blank abutments are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations. The customized Pre-Milled Blank abutment will be attached to a dental implant using the included ARUM Dentistry prosthetic screw.
ARUM Dentistry's Pre-Milled Blanks are compatible with the implant systems listed in the Compatibility Table:
| ARUM Pre-Milled Blank | | Implant Platform
compatibility | Restorative Platform
diameter [mm] | Implant Body
diameter [mm] | Abutment
Screw |
|-----------------------|---------|-----------------------------------|---------------------------------------|-------------------------------|-------------------|
| Ø10 mm | Ø14 mm | | | | |
| CIHE037 | CIHE038 | NobelActive NP | 3.5 | 3.5 | CSTO001 |
| CIHE039 | CIHE040 | NobelActive RP | 3.9 | 4.3/5.0 | CSTO002 |
| CIHE135 | CIHE136 | NobelActive WP | 5.1 | 5.5 | CSTO002 |
All digitally-designed Pre-Milled Blank abutments are intended to be sent to an ARUM Dentistry-validated milling center for manufacture.
ARUM Dentistry Co., Ltd.'s Pre-Milled Blank abutments are a system of dental implant abutments which have an implant /abutment interface design compatible with the Reference device OEM Nobel Biocare NobelActive implant system. Each Subject device implant abutment has a pre-manufactured implant interface connection interface with a customizable cylindrical section above the implant/abutment interface. The compatible implant body diameters range from 3.5 to 5.5 mm, with restorative interface diameters ranging from 3.0 to 5.1 mm (NP, RP and WP diameters).
The Subject device abutments and corresponding abutment screws are all pre-manufactured from Ti-6Al-4V ELI (Grade 23) titanium conforming to ASTM F136 and provided non-sterile to the user.
The Subject device abutments are in two customizable-section diameters for each restorative interface. The cylindrical section of the Subject device abutments are intended to be customized by means of CAD/CAM technology to provide basis or support for single or multiple tooth prosthetic restorations. All digitally designed custom abutments from titanium blank abutments are to be sent to an ARUM Dentistry Co., Ltd.-validated milling center for manufacture.
This document is an FDA 510(k) premarket notification for a medical device called "Pre-Milled Blank" (K193425). It details the device's administrative information, classification, predicate device, description, indications for use, and a comparison to the predicate device to demonstrate substantial equivalence.
While the document thoroughly addresses the substantial equivalence of the "Pre-Milled Blank" device to a predicate device based on indications for use, technological characteristics, and non-clinical performance data, it does not contain information related to an AI/ML-based medical device performance study.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth, or training set specifics, as these are evaluation criteria typically applied to AI/ML devices.
The "Pre-Milled Blank" is a physical dental implant abutment, and its approval is based on demonstrating equivalence to an existing device through non-clinical performance data (sterilization, biocompatibility, mechanical testing) rather than through AI/ML model 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.)