(45 days)
The drill is used to pre-drill into the maxilla or mandible to create an initial osteotomy for the later endosseous dental implant placement. The drills are used with a handpiece.
CeraDrill is a ceramic drill for the dental implantology made of a modern high performance ceramic. The drills are intended to be used with a handpiece. The intended use for this device is to cut into the maxilla or mandible to create an osteotomy for endosseous dental implant placement.
CeraDrills within the new "CeraLine" is intended for use in implantology. These are made of high efficiency ceramics featuring an excellent cutting performance. The new CeraDrill offers the possibility of working without any metal, thus guaranteeing a biocompatible operation. Damages, as they occur in particular when disinfecting and cleaning steel burs with inappropriate agents, are now a thing of the past. The multifunctional ceramic drills are suited for initial preparation of the implant site axis and depth. The drills feature high initial sharpness and optimal cutting efficiency, thus achieving an effective material reduction. Due to their high efficiency toothing and the distinct tip-transversing blade, the drill has very good axial drilling properties for precise cutting without the need for prior use of a centering bur. The special twist drill blade geometry ensures smooth and precise operation. Moreover, the depth markings, which are lasered on to the working part in 2 mm intervals guarantee precise and safe control of the penetration depth. The CeraDrill family is available in diverse dimensions and shapes for the individual preparation on the osteotomy.
This is a submission for a 510(k) premarket notification for a dental device, specifically a bone-cutting instrument. These types of devices generally rely on demonstrating substantial equivalence to a predicate device rather than undergoing extensive clinical trials as typically seen for novel medical devices or diagnostic algorithms. Therefore, the information provided focuses on non-clinical performance and technological characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Aspects from "Summary of technological Characteristics" & "Mechanical Stability") | Reported Device Performance (CeraDrill) |
|---|---|
| Energy used and/or delivered | Intended to be used in electrical powered hand pieces (Same as predicate) |
| Design | Two/three cutting flutes, external irrigation (Predicate device had internal/external irrigation) |
| Performance (Concenticity) | Ordinary concentricity (Same as predicate) |
| Corrosion Resistance | Corrosion resistive; not leading to decolourisation while reprocessing (Improved over predicate's limited resistance) |
| Materials | Zirconium oxide (ZrO2/Al2O3/Y2O3); single material, no coating, limited probability of abrasion (Advantage over predicate's coated stainless steel) |
| Biocompatibility | According ISO 7405 (Same as predicate) |
| Ability to be reprocessed | Can be used, cleaned, disinfected, and sterilized for at least 10 cycles (demonstrated in test report #06m1166) |
| Mechanical stability after reprocessing | Reprocessed in 100 cycles without significant loss of mechanical stability (details in chapter 18 d) |
| Thermal safety | Improved thermal safety; lower temperature rise observed with ceramic burs compared to steel burs (details in chapter 18 a) |
| Resistiveness against bending forces | Assumable lower resistiveness against bending forces during operation is negligible (fracture would lead to unacceptable osteotomies/misuse) |
2. Sample Size Used for the Test Set and Data Provenance
The submission does not specify a "test set" in the context of an AI/ML algorithm or a diagnostic test with patient data. Instead, it refers to non-clinical tests conducted on the CeraDrill devices themselves to evaluate their physical and biological characteristics. The data provenance is internal testing by the manufacturer (Gebr. Brasseler GmbH & Co. KG), and the studies are prospective in the sense that they were designed and executed to test the characteristics of the new device. No geographical origin of patient data is relevant here as it's not a clinical study involving patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study that involves expert review for ground truth in the context of diagnostic accuracy. The "ground truth" for the non-clinical tests would be the measured physical and biological properties of the device, assessed using established engineering and laboratory standards.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this submission describes non-clinical performance data, not a study evaluating human interpretation or a diagnostic outcome requiring adjudication.
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
No MRMC comparative effectiveness study was done. This device is a surgical instrument, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No standalone algorithm performance study was done. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the evaluation of the CeraDrill's performance is based on engineering and laboratory test results for mechanical stability, thermal safety, corrosion resistance, material composition, and biocompatibility, as determined by internal testing and adherence to relevant standards (e.g., ISO 7405 for biocompatibility).
8. The Sample Size for the Training Set
Not applicable. There is no training set as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set.
§ 872.3240 Dental bur.
(a)
Identification. A dental bur is a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone. It is also intended to cut hard metals, plastics, porcelains, and similar materials intended for use in the fabrication of dental devices.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.