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K Number
K062064
Device Name
RIVA BOND LC
Manufacturer
SOUTHERN DENTAL INDUSTRIES, INC.
Date Cleared
2006-11-09

(112 days)

Product Code
EMA
Regulation Number
872.3275
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • · For direct bonding of composite resin to dentin and enamel.
  • · For direct bonding of composite resin to dentin and enamel in the co-cured technique.
  • · For direct bonding of composite resin to GI self cure or GI light cure base base base on and enamel in the "sandwich" technique.
  • · For · sealing to hypersensitive cervical areas and root surfaces of teeth.
Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the Riva Bond LC device. The document is a 510(k) premarket notification letter from the FDA, confirming the substantial equivalence of the Riva Bond LC to a legally marketed predicate device. It defines the indications for use but does not include details about performance studies or acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.

§ 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.