(167 days)
Benda Wedge is an inter-proximal wedge coated with an astringent to be used in combination with other devices to temporarily retain composite or amalgam restorative material as well as to control gingival bleeding during dental restorations.
Benda Wedge is indicated for use as a temporary inter-proximal wedge during dental restorative procedures. Benda Wedge is similar in design to the Wedge Wand predicate device but includes a hemostatic agent to control gingival bleeding. Design features consist of the following: Available in four anatomically-shaped sizes for optimum placement in inter-proximal spaces. Use an injection-molded thermoplastic material which is then coated with a fixed amount of aluminum sulfate hexadecahydrate to help control gingival bleeding.
This document describes a medical device, the "Benda Wedge," which is a dental wedge coated with a hemostatic agent. The submission is a 510(k) premarket notification, indicating that the manufacturer is seeking to demonstrate substantial equivalence to previously cleared devices rather than providing extensive de novo clinical trial data.
Acceptance Criteria and Device Performance:
The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., specific reduction in bleeding, retention strength, etc.). Instead, the entire submission is built around demonstrating substantial equivalence to predicate devices. The "reported device performance" is implicitly that it performs comparably to the predicate devices for its intended use, with the added benefit of a hemostatic agent.
Therefore, the table below reflects the primary claim of similarity rather than specific performance numbers.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantially equivalent in design to predicate dental wedges. | "Benda Wedge is similar in design to the Wedge Wand predicate device..." |
| Utilizes thermoplastic material. | "Both Benda Wedge and predicate wedge device use thermoplastic material..." |
| Available in multiple sizes. | "Available in four anatomically-shaped sizes for optimum placement in inter-proximal spaces." and "Available in 4 model sizes of wedge incorporating the same basic design as predicate wedge device." |
| Same intended use as predicate dental wedges. | "Same intended use as wedge predicate device." (Intended use: to temporarily retain composite or amalgam restorative material during dental restorations.) |
| Same operating principle as predicate dental wedges. | "Same operating principle as wedge predicate device." |
| Hemostatic agent chosen is comparable in identity, mode of operation, and amount to predicate cord devices containing astringents. | "Benda Wedge is then coated with an astringent agent to control gingival bleeding." and "Astringent chosen for subject device is comparable in identity, mode of operation and amount to predicate cord device." (The specific astringent mentioned is aluminum sulfate hexadecahydrate.) |
| Biocompatible for its intended use. | "Biocompatibility testing was performed on the subject device in conformance with ISO 10993-1 guidelines." (Results of this testing are not provided in the summary.) |
1. Sample sizes used for the test set and data provenance:
- Test Set Sample Size: "Clinical testing has not been performed on this product." Therefore, there is no test set in the traditional sense, and thus no sample size for clinical performance evaluation. Non-clinical biocompatibility testing was performed, but sample sizes for this are not specified in the summary.
- Data Provenance: Not applicable, as no clinical testing was performed.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical testing was performed and no ground truth for a test set was established.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable, as no clinical testing was performed and no ground truth for a test set was established.
4. 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:
- Not applicable. This device is a physical dental wedge, not an AI-powered diagnostic or assistive tool for human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical dental wedge, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable, as no clinical testing was performed. For the biocompatibility testing, the ground truth would typically be established by standardized laboratory tests and evaluations against ISO 10993-1 guidelines, with results interpreted by qualified toxicologists or materials scientists.
7. The sample size for the training set:
- Not applicable. This device is a physical dental wedge and does not involve AI or machine learning that would require a training set.
8. How the ground truth for the training set was established:
- Not applicable, as no training set was used.
§ 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.