CrystLCare™ PRO Biorestorative, Fluoride-Plus

CrystLCare™ PRO Biorestorative, Fluoride-Plus is a flavored dental strip containing calcium, phosphate, and fluoride stabilized with modified starch. Applied topically to tooth surfaces experiencing dental sensitivity, the strip dissolves in saliva to release minerals that form a fluorohydroxyapatite crystal layer occluding exposed dentin tubules and relieving discomfort.

Both the subject device and predicate (Relief® ACP Oral Care Gel) release mineral components in saliva to crystallize on tooth surfaces and occlude dentin tubules. The subject device is a single-component dental strip requiring no mixing, while the predicate is a two-component gel mixed via dual barrel syringe. Both contain sodium fluoride, potassium nitrate, apatite-forming ingredients (calcium and phosphate ions), thickener, surfactant, flavoring, sweetener, and water. The subject device is single-use professional application; the predicate is home-use applied 1–2 times daily for up to four weeks.

Not stated in this summary. The document references Scanning Electron Microscopy (SEM), Electron Dispersive X-ray (EDX) spectroscopy, and X-Ray Diffraction (XRD) analysis but does not cite specific consensus standards (ISO, IEC, ASTM, etc.).

Non-clinical testing demonstrated equivalent dentin tubule occlusion: SEM micrographs showed both devices deposited similar fluorohydroxyapatite layers onto tooth surfaces, and EDX/XRD confirmed equivalent mineral crystallization and layer formation. Although fluoride release was lower in the subject device, this raised no new safety or effectiveness concerns. Since both devices operate identically—releasing minerals in saliva to form occlusive crystals—and testing showed equivalent performance in occluding dentin tubules, the subject device is substantially equivalent in intended use, materials, and principles of operation to the predicate.