LogoFDA 510(k) Search
K Number
K012529
Device Name
ROK
Manufacturer
SOUTHERN DENTAL INDUSTRIES, LTD.
Date Cleared
2001-10-22

(77 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
Dental
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

High density restorative for cavity preparation in posterior teeth. May be used as an indirect restorative for inlays and onlays.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental device called "ROK." It primarily confirms the device's substantial equivalence to a legally marketed predicate device and does not contain information about the acceptance criteria or a study proving the device meets specific performance criteria.

Therefore, I cannot provide the requested information based on the input text. The document focuses on regulatory approval based on equivalence, not on a detailed performance study with acceptance criteria.

§ 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.