(166 days)
DRFP propoint obturation points are designed for permanent sealing of root canals when used with DRFP smartpaste Dental Sealer or Brasseler USA EndoSequence® BC Sealer following established endodontic procedures by qualified healthcare professionals.
The propoints are identical to the points cleared for marketing with K100248. They are made of a radiopaque core and an opaque hydrophilic coating of cross-linked hydrophilic polymers that have been used in the contact lens industry for more than 20 years.
propoints are offered in the traditional 4% and 6% sizes and for use with variable taper files (such as ProTaper™ and Sendoline S5™). They are biocompatible and fully opaque. The hydrophilic coating expands radially to push the sealer into irregularities and voids present in the root canal system for a tight mechanical seal with the dentine. The coating only expands into available space and does not exert pressure on tooth structures. Dimensional length stability is maintained.
The points are packaged in clean room conditions and come individually wrapped to prevent cross-contamination. They can be cut to exact tip size and length.
No heating or compression equipment is required. Post insertion can commence immediately after root canal has been filled. The hydrophilic properties of the device allow extraction without softeners in revision procedures.
propoints are
- coated with DRFP smartpaste prior to insertion into the root canal . (K100248) or
- inserted after the root canal has been filled with EndoSequence® BC. .
This report describes the acceptance criteria and study that proves the device meets the acceptance criteria for DRFP Ltd.'s Propoints with iRoot SP Sealer.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Effective bonding with dentin and dentin tubules in root canal | Yes |
| Meets Bench Test Criteria in Dye Ingress Test | Yes (No sign of dye ingress after sectioning and assessment under a microscope in in-vitro dye penetration tests using heat-sterilized extracted teeth filled with EndoSequence® and propoints and immersed in Brilliant Blue Dye solution for at least one week.) |
| Effect of Interaction with Sodium Hypochlorite / EDTA residual levels after rinsing 3 times | None (Remaining 0.01% sodium hypochlorite after rinsing 3 times had no effect; undiluted 17% EDTA had no effect on the system.) |
| Biocompatible | Yes (Materials shown to be non-toxic, non-carcinogenic, and biocompatible with tissue fluids according to ISO 10993 and ISO 7405.) |
| Reported Failure Rate in Clinical Use | 0.8% (Out of approximately 2000 treatments, predominantly attributed to tooth rather than material problems.) |
| Radiopacity in Clinical X-rays | Good (Clinical X-rays validate excellent radiopacity of both devices and confirm effective bonding to tooth structures and provide evidence of good healing.) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Approximately 2000 treatments were reviewed for clinical performance.
- Data Provenance: The clinical data is retrospective, derived from the "DRFP User Panel of practicing dentists". The country of origin for the data is not explicitly stated, but the submission is from DRFP Ltd. in the United Kingdom and their "User Panel" is mentioned, implying data collected from dental practices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: A "DRFP User Panel of practicing dentists" was used. The exact number of dentists on this panel is not specified.
- Qualifications of Experts: They are described as "practicing dentists." Their specific qualifications (e.g., years of experience, specialization) are not detailed in the provided text.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The failure rate and clinical observations appear to be reported directly by the "DRFP User Panel of practicing dentists."
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of an MRMC comparative effectiveness study, nor is AI involved in this device. This submission is for a conventional medical device (root canal obturation points and sealer).
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical medical device (root canal obturation system), not an algorithm or AI.
7. The Type of Ground Truth Used
- For Clinical Performance: The ground truth for clinical performance (failure rate, healing, bonding effectiveness) was established through observations and reporting by a "DRFP User Panel of practicing dentists" and confirmed through "clinical x-rays."
- For Bench Tests: The ground truth for bench tests (dye penetration, sodium hypochlorite/EDTA interaction, radiopacity) was based on laboratory measurements and visual assessment (e.g., microscopic assessment for dye ingress).
- For Biocompatibility: Ground truth was established by testing according to ISO 10993 and ISO 7405 standards.
8. The Sample Size for the Training Set
There is no mention of a "training set" in the context of an algorithm or AI. This submission is for a physical medical device, not an AI/ML product.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as there is no "training set" for an algorithm.
§ 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.