FRC POSTEC PLUS

• K Number: K042848
• Device Name: FRC POSTEC PLUS
• Manufacturer: IVOCLAR VIVADENT, INC.
• Date Cleared: 2004-11-22 ( 38 days)
• Product Code: ELR
• Regulation Number: 872.3810
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

Intended for use by dentists to give retention for reconstruction of endontically treated teeth.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for a dental device (FRC Postec Plus) and primarily focuses on regulatory approval based on substantial equivalence to a predicate device. It does not detail specific performance acceptance criteria or the study design and results as requested in your prompt.

Regulation Number and Section

§ 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.