(54 days)
To aid in the relief from dentinal sensitivity caused by cold, heat, acids, sweets, or as the result from dental whitening agents.
Super Seal ® Tooth Desensitizer is applied with an applicator by the user to aid in dentinal sensitivity. It contains an organic salt that reacts with the calcium hydroxyapatite in the dentinal tubules. The formation of these calcium oxalate crystals inhibits and blocks fluid flow in the tubules, thereby relieving dentinal sensitivity.
The provided document describes the Super Seal® Tooth Desensitizer (K120109), which is a tooth desensitizer intended to aid in the relief from dentinal sensitivity.
Here is an analysis of the acceptance criteria and the studies that prove the device meets these criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance and Evidence |
|---|---|
| Primary Mechanism of Action: Occlude dentinal tubules, blocking fluid flow. | Evidence: |
- Kolker et al. (in-vitro study): Evaluated the effect on permeability, hydraulic conductance, and morphological tubule change. Showed "a reduction in dentin permeability and a conical occlusion of the tubules for Super Seal®."
- Suzaki et al. (follow-up study): "confirming tubule occlusion."
- Duran et al. (study on HEMA products, cited for comparison): Showed a decrease in permeability by tubule occlusion for HEMA based products (this offers context for the concept of tubule occlusion as a mechanism, though Super Seal® is described as having a different chemical mechanism than HEMA products).
Reported Performance: The device's technological characteristic section explicitly states, "Super Seal® Tooth Desensitizer ... reacts with the calcium hydroxyapatite of the surface and peritubular dentin to form calcium oxalate crystals occluding the tubules." The in-vitro studies confirm this functional occlusion. |
| Clinical Effectiveness: Aid in the relief from tooth sensitivity. | Evidence:
- Suzaki et al. (in-vivo portion): "evaluated 100 cases of human sensitivity and showed Super Seal® was effective to stop patient hypersensitivity." The specific measure of effectiveness (e.g., percentage reduction in sensitivity, duration of relief) is not detailed in the summary. |
| Safety: No adverse effects or safety issues. | Evidence: - Overall statement: "No adverse effects or safety issues pertaining to Super Seal® were found in any of the studies." |
| Substantial Equivalence to Predicates: | Evidence: - The conclusion explicitly states, "From the nonclinical and clinical tests that were preformed we conclude that Super Seal® Tooth Desensitizer is substantially equivalent to the predicate devices." This implies that the performance in terms of mechanism, effectiveness, and safety is comparable to the predicate devices (Protect Tooth Desensitizer K050486 and Orajel Advanced Tooth Desensitizer K041680). The commonality in the mechanism discussed with predicates (occluding dentinal tubules) supports this. |
2. Sample Size Used for the Test Set and Data Provenance
- Suzaki et al. (in-vivo portion):
- Sample Size: 100 cases of human sensitivity.
- Data Provenance: Human sensitivity cases, implying a clinical study with patients. The country of origin is not specified, but it is an in-vivo study. It is implied to be a prospective study as it "evaluated 100 cases" to show effectiveness.
- Kolker et al. and Suzaki et al. (in-vitro portions): The sample sizes for these in-vitro studies (permeability, hydraulic conductance, morphological tubule change, tubule occlusion) are not specified in the summary. Data provenance is implied to be laboratory research.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the summary. The studies mentioned (Kolker et al. and Suzaki et al.) would have involved researchers and clinicians, but the specific number and qualifications of experts for establishing ground truth (e.g., diagnosing sensitivity, assessing occlusion) are not detailed.
4. Adjudication Method for the Test Set
- This information is not provided in the summary. For in-vivo studies assessing patient hypersensitivity, expert assessment would typically be involved, but no specific adjudication method (like 2+1 or 3+1 consensus) is outlined.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The studies mentioned focus on the performance and safety of Super Seal® itself, and its comparison to predicates for substantial equivalence. There is no mention of human readers or AI assistance in the context of this device. The device is a direct-application dental product, not an imaging or diagnostic AI system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical product (tooth desensitizer), not an algorithm or AI system. Therefore, the concept of a "standalone" algorithm performance study does not apply.
7. The Type of Ground Truth Used
- In-vitro studies (Kolker et al. & Suzaki et al. on occlusion/permeability): Ground truth was likely established through objective laboratory measurements (e.g., permeability measurements, microscopic analysis of tubule occlusion).
- In-vivo study (Suzaki et al. on human sensitivity): Ground truth for "patient hypersensitivity" would have been based on patient reported symptoms or clinical assessment of sensitivity, likely by a dentist or dental professional. Outcomes data (relief from sensitivity) served as the measure of effectiveness.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical product, not an AI/algorithm that requires a training set. The term "training set" doesn't apply in the context of conventional medical device performance studies for a topical treatment.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of device.
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.