(149 days)
System for cleansing, sealing and filling of root canals consisting of 3 products: Canal Cleaner, DC Canal Seal SE, and DC Root XR.
Canal Cleaner is a carbamide-peroxide and EDTA-containing gel in syringes for use in the effective cleansing of the root canal during root canal preparation.
DC Canal Seal SE is a simple to use selfetching dual cure sealer for conditioning of root canals and for sealing of side tubuli.
DC Root XR is a dual cure flowable root canal sealing and filling material based on methacrylates.
System for cleansing, sealing and filling of root canals consisting of 3 products: Canal Cleaner, DC Canal Seal SE, and DC Root XR.
Canal Cleaner is a carbamide-peroxide and EDTA-containing gel in syringes.
DC Canal Seal SE is a selfetching dual cure sealer.
DC Root XR is a dual cure flowable root canal sealing and filling material based on methacrylates.
The provided text is a 510(k) clearance letter from the FDA for a dental device called "Root Canal XR". This letter grants clearance based on substantial equivalence to a predicate device. It addresses regulatory compliance rather than presenting clinical study results with acceptance criteria.
Therefore, the requested information regarding acceptance criteria, device performance, study details (sample sizes, provenance, expert ground truth, adjudication), MRMC studies, standalone performance, and training set information cannot be extracted from this document.
This document primarily:
- States the device name and regulation number.
- Confirms substantial equivalence to a predicate device.
- Outlines general regulatory requirements for the manufacturer.
- Specifies the "Indications for Use" for the three products comprising the Root Canal XR system (Canal Cleaner, DC Canal Seal SE, and DC Root XR).
There is no mention of performance metrics, clinical studies, or criteria for device acceptance in terms of efficacy or safety data in this clearance letter.
§ 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.