LogoFDA 510(k) Search
K Number
K003221
Device Name
HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST
Manufacturer
HARALD NORDIN S.A
Date Cleared
2000-10-25

(9 days)

Product Code
ELR
Regulation Number
872.3810
Type
Special
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 872.3810 Root canal post.

(a)
Identification. A root canal post is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be cemented into the root canal of a tooth to stabilize and support a restoration.(b)
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 the limitations in § 872.9.