(57 days)
A dental matrix band is a non-sterile single use disposable device intended to be place around a tooth to keep filling material from bonding onto the other tooth. Matrix bands are used to form missing walls of prepared teeth. They shape and confine restorative materials to areas prepared to receive restorations.
The Dental Matrix Band is made of medical grade stainless steel with a tin coating. The dental matrix bands are offered non-sterile single use.
This document describes a 510(k) premarket notification for a Dental Matrix Band, a Class I medical device. The information provided is primarily focused on establishing substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria in the way one would for a novel, higher-risk device or an AI/ML powered medical device.
Therefore, the requested AI/ML-specific information (expert consensus, training/test set details, MRMC studies, standalone performance, etc.) is not applicable to this submission. This is a conventional medical device that relies on material testing and comparison to an existing product.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use | The device is intended to be placed around a tooth to keep filling material from bonding onto the other tooth. It is used to form missing walls of prepared teeth, shaping and confining restorative materials. |
| Size and Configuration | Substantially equivalent to Dentsply, Inc., Dental Matrix Band. Specific sizes and configurations are not detailed but are implied to match the predicate. |
| Base Material | Made of medical grade stainless steel with a tin coating. Considered substantially equivalent to Dentsply, Inc., Dental Matrix Band. |
| Biological Evaluation (Biocompatibility) | Materials were tested per ISO 10993 Biological Evaluation for Medical Devices for a "surface indicating, skin, limited exposure device". |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is not a study involving human data or a "test set" in the context of an AI/ML algorithm. The "testing" referred to is materials testing for biocompatibility.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth for a test set (in an AI/ML context) is not relevant for this device.
4. Adjudication Method for the Test Set
Not applicable.
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
No such study was conducted or is relevant for this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used
Not applicable in the context of AI/ML. The "ground truth" for this device's performance is established by its material properties meeting ISO 10993 standards and its physical characteristics (intended use, size, configuration, material) being comparable to a legally marketed predicate device.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device.
Study that Proves the Device Meets the Acceptance Criteria:
The "study" referenced for this device is a "Summary of Testing" which states:
- Materials were tested per ISO 10993 Biological Evaluation for Medical Devices for a surface indicating, skin, limited exposure device.
This indicates that biocompatibility testing was performed according to internationally recognized standards for medical devices. The specific results of this testing (e.g., passing specific cytotoxicity, sensitization, or irritation tests) are not detailed in this summary but are implicit in the claim of testing per ISO 10993.
The primary proof of the device meeting its acceptance criteria (beyond biocompatibility) is its substantial equivalence to a predicate device, the Dentsply, Inc., Dental Matrix Band. The argument for substantial equivalence is based on the new device sharing the same:
- Intended use
- Size and configuration
- Base material
The FDA's decision to clear the device (K071858) confirms that they found sufficient evidence of substantial equivalence to the predicate device, implying that the provided testing and comparative analysis were deemed adequate.
§ 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.