ACROSEAL ROOT CANAL OR APICAL SEALER

• K Number: K023976
• Device Name: ACROSEAL ROOT CANAL OR APICAL SEALER
• Manufacturer: SEPTODONT S.A.S.
• Date Cleared: 2003-01-30 ( 64 days)
• Product Code: KIF
• Regulation Number: 872.3820
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Permanent canal filling

Device Description

Not Found

AI/ML Overview

This document is a marketing clearance letter from the FDA for a medical device (ACROSEAL Root Canal Sealer), not a study report. Therefore, it does not contain any information regarding specific acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies.

The letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to proceed to market. This determination is based on the information provided in the Section 510(k) premarket notification. The letter also lists general regulatory requirements that the manufacturer must follow.

To provide the requested information, you would need to access the actual 510(k) premarket notification submitted by Septodont S.A.S. for ACROSEAL Root Canal Sealer, as that document would contain the details of any testing and performance data relied upon for the substantial equivalence determination.

Regulation Number and Section

§ 872.3820 Root canal filling resin.

(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.