(81 days)
Renamel Scuptable Composite is used in Class II , Class V Restorations and to build up the lingual wall on Class IV anterior restorations.
Renamel Sculpt Composite is a system consisting of light cured composite restorative materials.
The provided document is a 510(k) premarket notification letter from the FDA to Cosmedent, Inc. regarding their Renamel Sculpt device. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
The letter confirms that the FDA has reviewed the 510(k) notification and determined that Renamel Sculpt is "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to market. The "Indications for Use Statement" on page 2 specifies that Renamel Sculpt is used in Class III, Class V Restorations and to build up the lingual wall on Class IV anterior restorations. The "Description of Device" states that it is a system consisting of light-cured composite restorative materials.
Without further documentation, it is impossible to answer the specific questions about acceptance criteria and study details. Such information would typically be found in the 510(k) submission itself or in performance test reports, which are not part of this letter.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.