(196 days)
Butler® Calci-Flor Prophylaxis Paste is designed to clean and polish teeth during professionally administered dental hygiene prophylaxis treatments.
Butler® Calci-Flor Prophylaxis Paste is intended for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment.
Butler® Calci-Flor Prophylaxis Paste is an oral cavity abrasive polishing agent that contains calcium and fluoride. This device is regulated by FDA as a Class I device.
Butler® Calci-Flor Prophylaxis Paste is an abrasive oral prophylaxis paste (available in one of several levels of grit coarseness), which contains fluoride, calcium, humectants, bulking agents for proper paste formation, a sweetener, flavor, color, and preservatives. This device is intended for use by dental professionals, during professionally administered dental prophylaxis treatment (tooth-cleaning), to remove stain from and polish the teeth. Paste application is designed for use with a prophy angle with suitable cup. The device is to be limited to individuals who are professionally trained to perform dental prophylaxis.
The provided document is a 510(k) premarket notification for a dental prophylaxis paste, Butler® Calci-Flor Prophylaxis Paste. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. Therefore, much of the requested information regarding clinical studies, ground truth, and expert adjudication is not present in this type of submission.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This type of data is not typically presented in a 510(k) submission for a Class I device seeking substantial equivalence based on material composition and intended use. The submission focuses on demonstrating that the new device is "at least as safe and effective as the legally marketed predicate device" through bench testing and comparison of characteristics.
- Acceptance Criteria (Implicit): The implicit acceptance criteria are that the device's characteristics (material composition, intended use, duration of patient contact) are substantially equivalent to predicate devices, and that any new testing (fluoride release) does not raise new questions of safety and effectiveness.
- Reported Device Performance:
- Material Composition: "Butler® Calci-Flor Prophylaxis Paste is made of the same ingredient component materials that are used in lawfully marketed predicate devices..."
- Intended Use/Indications: "...has the same indications for use and intended use as lawfully marketed predicate devices."
- Patient Contact: "...with the same type and durations of patient contact."
- Fluoride Release Data: "Bench testing was performed on the Butler® Calci-Flor Prophylaxis Paste to ascertain fluoride release data." The results "do not raise new questions of safety and effectiveness."
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided because a clinical test set, in the sense of a patient cohort or a large dataset, was not used. The testing described is "bench testing" for fluoride release. Details of this bench testing, including any sample sizes for the laboratory tests, are not elaborated upon in this summary document.
- Data Provenance: Not applicable as no clinical test set was described.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth, in the context of clinical studies with expert adjudication, is not relevant to this 510(k) submission, which relies on demonstrating substantial equivalence through material comparison and bench testing.
4. Adjudication Method for the Test Set
Not applicable, as no test set requiring clinical adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable, as the device is a prophylaxis paste, not an algorithm or AI system.
7. The Type of Ground Truth Used
The concept of "ground truth" as pathology, outcomes data, or expert consensus is not applicable here. The "truth" in this submission relies on:
- The known characteristics and regulatory history of predicate devices.
- The chemical composition of the new device.
- The results of basic bench testing (fluoride release).
8. The Sample Size for the Training Set
Not applicable. The device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, for the same reason as point 8.
§ 872.6030 Oral cavity abrasive polishing agent.
(a)
Identification. An oral cavity abrasive polishing agent is a device in paste or powder form that contains an abrasive material, such as silica pumice, intended to remove debris from the teeth. The abrasive polish is applied to the teeth by a handpiece attachment (prophylaxis cup).(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.