(2 days)
The SmartMTA Capsule is indicated for use as:
- Orthograde root canal filling material
- Repair of root perforations during root canal therapy (endodontic therapy), or as a consequence of internal and external resorption.
- Repair of root canals as an apical plug during apexification
- Root end filling
- Pulp capping
- Pulpotomy/Partial Pulpotomy
The major compositions of the SmartMTA Capsule are Calcium Carbonate (CaCO3), Silicon Dioxide (SiO₂), Aluminum Oxide (Al₂O₃), Zirconium Oxide (ZrO₂) and Distilled water and it has been showing good sealing ability and biocompatibility. It is prepared as a mixture of powder and water and is used in a putty form which gradually hardens in the oral environment. SmartMTA Capsule is ideal for orthograde root canal filling. SmartMTA Capsule is compositionally formulated to have the physical properties, setting requirements and characteristics necessary for a clinically effective root canal filling material.
Here's an analysis of the acceptance criteria and study information based on the provided text, focusing on what is stated and explicitly noting what is not mentioned.
Device Name: SmartMTA Capsule
Predicate Device: RetroMTA-OrthoMTA II (K132825)
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present "acceptance criteria" for the device in the typical sense of a target performance threshold that must be met. Instead, it compares the SmartMTA Capsule's performance to the predicate device and relevant ISO standards, explaining deviations. The key performance metrics and their reported values are derived from the ISO 6876:2012 standard testing where applicable.
| Test / Performance Metric | Acceptance Criteria (from ISO 6876:2012) | Candidate Device (SmartMTA Capsule) Performance (200/140 ratio) | Candidate Device (SmartMTA Capsule) Performance (200/160 ratio) | Predicate Device (RetroMTA) Performance | Notes on Acceptance / Deviations |
|---|---|---|---|---|---|
| Flow | > 17mm | 9.375 mm | Not explicitly stated if it met > 17mm, but implied to be in the "established range" | Not tested | Candidate device (200/140 ratio) did not meet criteria, but explained as not critical due to intended use and hydrophilic nature. 200/160 ratio did fall in range. |
| Working Time | ≤ 30 min | Not tested | 20 minutes | Not tested | Candidate device (200/140 ratio) not tested/measurable according to standard. 200/160 appeared to meet the criteria. Explained as not critical due to intended use and hydrophilic nature, and dependency on water-to-cement ratio. |
| Setting Time | 3.5 hours ± 10% (3h30min ± 10%) | 60 minutes | 3h35 minutes | 2.5 minutes to 27 minutes | Candidate device (200/140 ratio) setting time of 60 minutes is significantly faster than 3.5 hours ± 10%. Candidate device (200/160 ratio) setting time of 3h35 minutes meets the criteria. Predicate showed a wide range, some much faster than the standard. |
| Film Thickness | ≤ 50μm | Not tested | 43μm | Not tested | Candidate device (200/140 ratio) not tested/measurable according to standard. 200/160 ratio met the criteria. Explained as not critical due to intended use. |
| Solubility |
§ 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.