(507 days)
The MM-SEAL is a root canal sealer packaged in a dual syringe used for filling of root canals with gutta percha points for endodontic treatments.
MM-SEAL is intended for use by qualified healthcare personnel trained in its use.
The MM-SEAL is a biocompatible root canal sealer packaged in a dual syringe used for filling of root canals with gutta percha points for endodontic treatments.
The device consists of two component (dual syringe) which are mixed before the use in the dental canal, onto a mixing plate with a spatula for 15-20 seconds or until the mixture become creamy and homogeneous.
Application: Thoroughly dry canals walls and apply MM-SEAL, avoiding the formation of air bubbles. Do not exceed the apical limit. Dip the tips of dry, disinfected Gutta-percha points in MM-SEAL. Insert one or more points in the root canal and condense the Gutta-percha. MM-SEAL can be used with thermoplasticized gutta-percha or gutta-percha coated obturator techniques.
MM-SEAL should not be used expiry date.
MM-SEAL is intended for use by qualified healthcare personnel trained in it use.
This submission is for a root canal sealer, MM-SEAL, a medical device, and therefore does not have acceptance criteria or study data of the type requested in the prompt (e.g., sample size, expert qualifications, adjudication methods, MRMC study, standalone algorithm performance, or ground truth types related to AI/ML device performance). The document provided is a 510(k) summary for a medical device seeking substantial equivalence to a predicate device, not a study report for an AI/ML system.
The performance section of the document states:
- "The performance of MM-SEAL has been evaluated following the standard ISO 6876, Dental root canal sealing materials..."
- "...the risk analysis has been conducted following ISO 14971..."
- "...the biological evaluation has been done following ISO 10993-1 Biological evaluation of medical devices."
The submission concludes that MM-SEAL is substantially equivalent to its predicate device (ADSEAL K042769) based on identical manufacturer, intended use, chemical composition, physical properties, manufacturing process, method of application, and similar user manual and packaging.
Since this device is not an AI/ML product, the questions regarding acceptance criteria, study details, and data provenance for such technologies are not applicable here.
§ 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.