RIVA LIGHT CURE

• K Number: K050870
• Device Name: RIVA LIGHT CURE
• Manufacturer: SOUTHERN DENTAL INDUSTRIES, INC.
• Date Cleared: 2005-06-03 ( 58 days)
• Product Code: EMA , EBC , EBF
• Regulation Number: 872.3275
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

Minimal Class I, II and III restorations. Class V restorations, deciduous teeth and geriatric restorations, core build-ups, root surface restorations, used as a base or liner, pit and fissure sealant, semi-permanent fillings.

Device Description

Not Found

AI/ML Overview

This is a letter from the FDA regarding the 510(k) premarket notification for the Riva Light Cure dental cement. It states the device is substantially equivalent to legally marketed predicate devices.

The document does not contain acceptance criteria for the device's performance, nor does it describe any study. Therefore, I cannot provide the requested information.

Regulation Number and Section

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
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 § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.