(107 days)
ANTHOGYR contra angles and handpieces are autoclavable devices intended for a wide range of procedures including implantology, endodontic surgeries and general dentistry.
ANTHOGYR's fully autoclavable contra-angles and handpieces are intended for use in a wide range of procedures including:
- Endodontic surgeries, such as root canal preparations
- Endodontic surgery such as perforating the bone, tapping and threading procedures
- Implant surgery such as perforating the bone, tapping and crown proper
- General dentistry such as removing carious material, cavity and crow preparation, finishing tooth preparations, restorations and polishing teeth
ANTHOGYR has developed a full range of reducing, multiplying and 1:1 contra angle and right hand-piece intended to be used in implantology, endodontic and general dentistry procedures. ANTHOGYR Contra angles design, size and performance conform to NF EN ISO 7785-2 "Dental Handpieces - Part 2: Straight and geared angle handpieces.
This document describes a 510(k) premarket notification for ANTHOGYR DENTAL HANDPIECES. The 510(k) summary focuses on the device's adherence to voluntary consensus standards rather than presenting a performance study with specific acceptance criteria and detailed results from a study. Therefore, the information requested in your prompt regarding specific acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not available in the provided text.
The submission states: "ANTHOGYR Contra angles & Handpieces conform to the following voluntary Consensus standards." This indicates that the device's performance is demonstrated by its compliance with recognized industry standards, rather than through a bespoke clinical or non-clinical study designed to meet specific new acceptance criteria.
Information that can be extracted from the provided text, related to your request, is as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to NF EN ISO 7785-2 "Dental Handpieces - Part 2: Straight and geared angle handpieces." | The device design, size, and performance "conform to NF EN ISO 7785-2". |
| Conformance to "voluntary Consensus standards" (specific standards not explicitly listed but implied by the successful 510(k) clearance). | The device "conform[s] to the following voluntary Consensus standards". |
| Autoclavable for sterilization. | The device is "fully autoclavable". |
| Intended for use in implantology, endodontic surgeries, and general dentistry. | The device is "intended for a wide range of procedures including implantology, endodontic surgeries and general dentistry." |
2. Sample size used for the test set and the data provenance: Not provided. The submission relies on conformance to standards, not a specific test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" was established based on expert consensus for a test set in the manner of a clinical study, as the submission relies on standards conformance.
4. Adjudication method for the test set: Not applicable. No test set requiring adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a dental handpiece, not an AI-powered diagnostic tool. MRMC studies are irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical dental device, not an algorithm.
7. The type of ground truth used: Conformance to established international and voluntary consensus standards (e.g., NF EN ISO 7785-2) for dental handpiece design and performance.
8. The sample size for the training set: Not applicable. This is a physical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established: Not applicable.
Summary of Device Performance and Study:
The ANTHOGYR Dental Handpieces (including Surgi Control, Endo Micro NiTi & NiTi Control, and General dentistry Contra angles) received 510(k) clearance (K040674) based on their substantial equivalence to legally marketed predicate devices and their conformance to relevant voluntary consensus standards.
The primary "study" and "acceptance criteria" presented in the provided text revolve around the device's compliance with established industry standards for dental handpieces. Specifically, the submission states that the "ANTHOGYR Contra angles design, size and performance conform to NF EN ISO 7785-2 'Dental Handpieces - Part 2: Straight and geared angle handpieces.'" It also mentions conformance to other "voluntary Consensus standards." This means that the device was designed, manufactured, and tested to meet the specifications and performance requirements outlined in these standards, which are internationally recognized benchmarks for safety and effectiveness of dental handpieces.
However, the 510(k) summary does not detail the specific tests conducted, the sample sizes used for those tests, or the raw data from such tests. Instead, it asserts that the device conforms to these standards, which is sufficient for regulatory clearance under the 510(k) pathway for Class I devices like dental handpieces.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.