(279 days)
The Tubli-Seal product line (Tubli-Seal Xpress/Tubli-Seal EWT/Tubli-Seal EWT Xpress) is used for permanent obturation of the root canal space with the aid of obturating points.
The Tubli-Seal product line (Tubli-Seal Xpress/ Tubli-Seal EWT/ Tubli-Seal EWT Xpress) is a Zinc Oxide Eugenol root canal sealer to be used for permanent obturation of the root canal space in conjunction with obturating points. It is a two-part, base/accelerator, paste/paste system that is mixed in equal portions. Then the mixture is carried to the root canal with endodontic obturation points, or directly dispensed in the root canal depending on delivery method, e.g. tube or dual-barrel syringe. The product is available in two (2) working times. Regular and Extended Work Time (EWT) for both delivery options of tubes or dual-barrel syringes.
The proposed is available packaged in tubes (Tubli-Seal and Tubli-Seal EWT) and dualbarrel syringes (Tubli-Seal Xpress and Tubli-Seal EWT Xpress) used with single-use automix tips. The tubes are dispensed onto a mixing pad, hand mixed and then applied to the canal with an endodontic point. Tubli-Seal Xpress has the same formulation and indications for use as Tubli-Seal, and Tubli-Seal EWT Xpress has the same formulation and indications for use as Tubli-Seal EWT. The proposed syringe-delivery products are branded as "Tubli-Seal Xpress" and "Tubli-Seal EWT Xpress" and offer the convenience of single-use automix tips that remove the need for hand mixing. The dual-barrel and single-use automix tips allow the dental professional to deliver the desired volume of Tubli-Seal Xpress or Tubli-Seal EWT Xpress directly into the prepped root canal.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
Device: Tubli-Seal product line (Tubli-Seal/Tubli-Seal Xpress/Tubli-Seal EWT/Tubli-Seal EWT Xpress)
This submission is for a modified version of an existing root canal sealer (Tubli-Seal/Tubli-Seal EWT). The core of the study is to demonstrate that the modified product line is substantially equivalent to the predicate device, essentially performing as well despite minor formula changes and a manufacturing location change.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are based on the international standard ISO 6876:2012 for Dental - Root Canal Sealing Materials. The reported performance of the proposed device is compared to the predicate device, with the standard as the overarching acceptance benchmark.
| Criterion (ISO 6876:2012) | Predicate Device Performance | Proposed Device Performance | Acceptance Criteria (from ISO 6876:2012) | Does Proposed Device Meet Criteria? |
|---|---|---|---|---|
| Consistency (Flow) | 29 mm | 28 mm | Not explicitly stated in the provided text as a numerical range (for a pass/fail), but is a characteristic measured. The slight difference (1mm) is considered acceptable for substantial equivalence. | Yes (implicitly, as considered substantially equivalent) |
| Film Thickness | 13.04 µm | 17.61 µm | Not more than 50 µm | Yes (17.61 µm |
§ 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.