LogoFDA 510(k) Search
K Number
K013277
Device Name
ASTRALIS 7, MODEL 557545
Manufacturer
IVOCLAR VIVADENT, INC.
Date Cleared
2001-10-22

(20 days)

Product Code
EBZ
Regulation Number
872.6070
Type
Traditional
Panel
DE
Reference & Predicate Devices
K013077
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Astralis 7 is a hand held polymerization unit used to cure dental composites

Device Description

Astralis 7 is a hand held polymerization unit

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, or ground truth for the "Astralis 7" device.

The document is a 510(k) premarket notification letter from the FDA to Ivoclar Vivadent, Incorporated, granting clearance for the "Astralis 7" as a "Ultraviolet Activator for Polymerization." It primarily addresses the legal and regulatory aspects of marketing the device, stating that it is substantially equivalent to legally marketed predicate devices. It also mentions general controls provisions of the Act that the manufacturer must comply with.

The section titled "Indications For Use" simply states: "Astralis 7 is a hand held polymerization unit used to cure dental composites."

Therefore, I cannot provide the requested table and study details as they are not present in the given text.

§ 872.6070 Ultraviolet activator for polymerization.

(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.