(94 days)
When used in the crown:
- Temporary enamel restorative material.
- Permanent dentine restorative material.
- Restoration of deep and/or large coronal carious lesions (sandwich technique).
- Restoration of deep cervical and/or radicular lesions.
- Pulp capping.
- Pulpotomy.
When used in the root:
- Repair of root perforations.
- Repair of furcation perforations.
- Repair of perforating internal resorptions.
- Repair of external resorption
- Apexification.
- Root-end filling in endodontic surgery (retrograde filling).
Biodentine is not to be used for permanent obturation or sealing of the root canal
Not Found
I am sorry, but the provided text does not contain information about the acceptance criteria and a study proving a device meets them. The text is a 510(k) premarket notification letter from the FDA to Septodont regarding their device Biodentine™. It discusses the regulatory approval of the device and its indications for use, but it does not detail any specific studies, acceptance criteria, or performance metrics.
Therefore, I cannot extract the requested information to fill in the table and answer the subsequent questions.
§ 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.