(83 days)
The device is used in combination with other dental devices to retain composite or amalgam restorative materials during dental restorations.
Matrix bands are used to retain composite and other restorative materials during dental restorations. In general a matrix band surrounds the tooth and is used to separate the teeth while a composite filling is placed. The type of band is selected based on the tooth height and restoration type. The dentist prepares the tooth and places the band on the tooth. A wedge is inserted for optimal contour, gingival seal, and tooth separation. A ring retainer such as the Composi-Tight 3D Ring or Composi-Tight 3D Thin Tine G Ring is used to hold the band in place. The band is removed after the application of composite resin. The devices are offered in different thicknesses, lengths, and widths to accommodate different sized teeth. Additionally, the device is offered in soft stainless steel and hard stainless steel depending on the preference of the dentist. The devices are offered in sectional matrix style or standard style (Tofflemire style). The Tofflemire style is a longer thinner band with or without lobes. The choice of style is dependent on the preference of the dentist and the specific condition and size of the patient's teeth.
Here's an analysis of the provided 510(k) summary for the "Slicks Matrix Bands & Sectional Matrix Bands," focusing on acceptance criteria and supporting studies:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility per ISO 10993 | The device was subjected to and successfully passed biocompatibility testing per ISO 10993. |
| Shear Force Performance | The device was subjected to and successfully passed performance testing to measure shear-force. |
| Substantial Equivalence to Predicate Devices | The manufacturer believes the subject devices are substantially equivalent to the predicate devices (Garrison Composi-Tight Sectional matrix bands, Waterpik Tofflemire bands, Young Dental Ho bands, Danville Sectional Matrix Bands) based on similar intended use, technological characteristics (except for a proprietary coating), and performance in biocompatibility and shear force testing. The FDA concluded that the device is substantially equivalent to legally marketed predicate devices. |
Study Details
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Sample Size and Data Provenance:
- Test Set: No specific sample sizes for the "test set" are provided for either biocompatibility or shear force testing. The document only states that the device "was subjected to" and "successfully passed" these tests. This likely implies that the tests were performed on representative samples of the Slicks Matrix Bands.
- Data Provenance: Not specified within the provided text.
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Number of Experts and Qualifications:
- Not applicable/Not specified. The biocompatibility and shear force tests are typically laboratory-based tests with objective endpoints, not requiring expert ground truth establishment in this context.
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Adjudication Method:
- Not applicable. As these are objective laboratory tests, there would not be an adjudication method in the context of expert review.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. The device is a dental instrument, not an AI or imaging diagnostic device where human reader performance is typically assessed and compared with or without AI assistance.
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Standalone Performance Study:
- Yes, for the specific performance attributes mentioned (biocompatibility and shear force), the device underwent standalone testing to demonstrate its inherent properties and performance. These tests were conducted on the device itself, independent of human interaction beyond the execution of the test protocol.
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Type of Ground Truth Used:
- Biocompatibility: The ground truth for biocompatibility is established by the pass/fail criteria defined within the ISO 10993 standard.
- Shear Force: The ground truth for shear force is likely a defined minimum force threshold or range that the matrix band must withstand, established by material science standards or internal engineering specifications relevant to dental applications. The text indicates "performance testing to measure shear force," implying a quantitative measure against a predetermined standard.
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Sample Size for Training Set:
- Not applicable. This is a medical device (matrix band), not an AI algorithm, so there is no "training set" in the context of machine learning.
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How Ground Truth for Training Set was Established:
- Not applicable, as there is no training set.
§ 872.4565 Dental hand instrument.
(a)
Identification. A dental hand instrument is a hand-held device intended to perform various tasks in general dentistry and oral surgery procedures. The device includes the operative burnisher, operative amalgam carrier, operative dental amalgam carver, surgical bone chisel, operative amalgam and foil condenser, endodontic curette, operative curette, periodontic curette, surgical curette, dental surgical elevator, operative dental excavator, operative explorer surgical bone file, operative margin finishing file, periodontic file, periodontic probe, surgical rongeur forceps, surgical tooth extractor forceps, surgical hemostat, periodontic hoe, operative matrix contouring instrument, operative cutting instrument, operative margin finishing periodontic knife, periodontic marker, operative pliers, endodontic root canal plugger, endodontic root canal preparer, surgical biopsy punch, endodontic pulp canal reamer, crown remover, periodontic scaler, collar and crown scissors, endodontic pulp canal filling material spreader, surgical osteotome chisel, endodontic broach, dental wax carver, endodontic pulp canal file, hand instrument for calculus removal, dental depth gauge instrument, plastic dental filling instrument, dental instrument handle, surgical tissue scissors, mouth mirror, orthodontic band driver, orthodontic band pusher, orthodontic band setter, orthodontic bracket aligner, orthodontic pliers, orthodontic ligature tucking instrument, forceps, for articulation paper, forceps for dental dressing, dental matrix band, matrix retainer, dental retractor, dental retractor accessories, periodontic or endodontic irrigating syringe, and restorative or impression material syringe.(b)
Classification. Class I (general controls). If the device is made of the same materials that were used in the device before May 28, 1976, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.