(86 days)
DURASHIELD® PLUS is indicated for the relief of dental hypersensitivity where dentin and cementum are exposed.
DURASHIELD® PLUS is a topically applied, flavored cavity varnish containing sodium fluoride and NovaMin. The varnish is a viscous liquid and is insoluble in water and saliva. NovaMin is a bio-available calcium phosphosilicate that releases calcium and phosphorous when exposed to moisture.
The provided text (K082198) is a 510(k) premarket notification for a dental product called DURASHIELD® PLUS. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy through clinical trials with specified acceptance criteria and performance data.
Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.
The submission primarily discusses:
- Device Name: DURASHIELD® PLUS
- Predicate Device: Sci-Pharm DFV Varnish
- Description: A topically applied, flavored cavity varnish containing sodium fluoride and NovaMin.
- Intended Use: Relief of dental hypersensitivity where dentin and cementum are exposed.
- Technological Characteristics: Similar to predicate device, with the addition of NovaMin for remineralization.
- Non-Clinical Performance Data: Components of DURASHIELD® PLUS passed biocompatibility testing; no additional biocompatibility tests were conducted for the final product.
- Conclusion: Substantially equivalent to the predicate device.
For medical devices, particularly those seeking 510(k) clearance, the focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device, not necessarily on meeting specific performance metrics from a de novo study. The FDA's letter confirms substantial equivalence, allowing the device to be marketed.
§ 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.