(59 days)
Indications:
- Indirect pulp capping
- Direct pulp capping
- Pulpotomy, after removal of affected coronal pulp to preserve vitality of remaining pulp tissue
Not Found
The provided text is an FDA 510(k) clearance letter for a dental device called "MTA vpt" (Root Canal Filling Resin). This letter does not contain any information about acceptance criteria or a study that proves the device meets those criteria.
The 510(k) clearance process is based on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy or meet specific performance metrics. Therefore, the details requested in your prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are generally not part of a standard 510(k) submission for this type of device.
To provide information related to your prompt, I would need a different type of document, such as a clinical study report, a performance testing report, or a summary of safety and effectiveness data, which are not included in this FDA clearance letter.
Based on the provided document, it is not possible to answer your request. The letter confirms the device's clearance based on substantial equivalence, but it does not detail the specific performance data or studies you're asking about.
§ 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.