(100 days)
BIOMET 31 Certain® Contoured Margin Ceramic Abutments are intended for use as an cessory to endosseous dental implants to support a prosthetic device in a partially or contains patient. The Certain® Contoured Margin Ceramic Abutments are intended for use support single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis is ment retained to the abutment.
The BIOMET 3i Certain® Contoured Margin Ceramic Abutment design consists of The BIOME I 37 Certains Contoured in buttent screw. These devices worldwords ffferent abutments $125, thanimi insort and all about - 11.00 as 1000 as 1000 and and propriate reatures and 311 with internal connections.
This 510(k) premarket notification is for a dental abutment, a mechanical device rather than an AI-powered one. Therefore, the questions regarding acceptance criteria, study details, ground truth, and training sets, which are typically relevant for AI/ML device submissions, do not apply here.
The document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, as per the FDA's 510(k) pathway for medical devices that are not significantly new in technology or intended use.
Here's why the AI-specific questions are not applicable and what this document does provide:
- No AI/ML Component: The device is a "Certain® Contoured Margin Ceramic Abutment," described as an accessory to endosseous dental implants. It's a physical component, not software with an algorithm.
- No Device Performance Metrics (in the AI/ML sense): For mechanical devices like this, "performance" would typically refer to mechanical strength, biocompatibility, fit, etc., tested through benchmarks, fatigue tests, material characterization, or preclinical studies. The document states "minor technological differences between the proposed devices components and their predicate devices raise no new issues of safety or effectiveness," implying that standard tests were likely performed to confirm no degradation in these mechanical properties compared to the predicate, but specific performance metrics are not listed in this summary.
- "Study" for 510(k) Substantial Equivalence: The "study" in this context is the comparison made by Biomet 3i to its own predicate device (BIOMET 3i Dental Ceramic Abutment) and a competitor's (Zimmer® Contour Ceramic Abutment). This comparison aims to show that the new device has the same intended use, indications, and technological characteristics, with no new issues of safety or effectiveness. This is a regulatory comparison, not a clinical trial or algorithm performance study.
Information provided in the document (relevant to a physical device submission):
- Device Name: Certain® Contoured Margin Ceramic Abutment
- Intended Use/Indications for Use: To support a prosthetic device in partially or completely edentulous patients, for single and multiple tooth prostheses in the mandible or maxilla, with the prosthesis cement-retained to the abutment.
- Technological Characteristics: Described largely by its composition (Zirconium oxide material), connections (internal and external), and screw type.
- Predicate Devices: BIOMET 3i Dental Ceramic Abutment and Zimmer® Contour Ceramic Abutment.
- Substantial Equivalence Claim: The device has the "same general intended uses, indications, technological characteristics," and that "minor technological differences... raise no new issues of safety or effectiveness."
To answer the user's request for acceptance criteria and study information, I would have to state that these concepts as they relate to AI/ML devices are not applicable to the provided 510(k) summary for this mechanical dental component. The "acceptance criteria" here is simply satisfying the FDA's requirements for demonstrating substantial equivalence, and the "study" is the comparison against predicates.
§ 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.)