(50 days)
The Roeko Seal root canal sealer is indicated in patients for permanent obturations of root canal after vital extirpation or after treatment of pulpal gangrene and temporary filling.
Roeko Seal is a permanent root canal filling material, which is silicone based (Polydimethylsiloxane) and consists additionally of zircondioxide, paraffin-based oil silicone oil, hexachloroplatinic acid and silicic acid.
The provided text is a 510(k) summary for a medical device called "Roeko Seal," a root canal filling material. It does not contain any information regarding acceptance criteria, device performance tables, study designs (sample sizes, data provenance, expert qualifications, adjudication methods), MRMC studies, standalone performance, ground truth types, or training set details.
The document primarily focuses on:
- Identification of the submitter and device.
- Classification of the device.
- Establishment of substantial equivalence to a predicate device (Lee Endo-Fill) based on technical characteristics (dimensional stability, flow, biocompatibility) and a general description of the material.
- FDA's response acknowledging the submission and determining substantial equivalence for the stated indications for use.
Therefore, I cannot provide the requested information from the given text. The text does not describe a study that validates the device's performance against specific acceptance criteria. Instead, it describes a regulatory submission seeking substantial equivalence to a pre-existing device.
§ 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.