(219 days)
Triumph Resin Dam is a resin-based, light-cured protective barrier material recommended to protect dental materials or tissues. For Use only by a Licensed Dentist. Rx Use Only.
Triumph Resin Dam is a light-cured, resin dam material recommended to block out or protect dental materials or tissues. Triumph contains polymerizable monomers that when light-cured form a protective barrier. When set the resin has a low strength allowing its removal from the protected surfaces.
This document is a 510(k) summary for a medical device called "Triumph Resin Dam," which is a resin-based, light-cured protective barrier material for dental use. The summary focuses on demonstrating substantial equivalence to a predicate device ("OpalDam") rather than presenting a study proving performance against acceptance criteria in the typical sense of a clinical trial for diagnostic AI.
However, I can extract the relevant information from the document to construct an answer aligned with your request, interpreting "acceptance criteria" as the criteria for demonstrating substantial equivalence and "study" as the comparison tests performed.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
For this type of device (a Class I dental resin dam), the "acceptance criteria" are essentially the characteristics and performance deemed equivalent to a legally marketed predicate device. The document primarily focuses on demonstrating substantial equivalence to the Opal Dam (K971284) and referencing BriteSmile (K010935) for hardness comparison.
| Property / Acceptance Criteria (as per predicate equivalence) | Reported Device Performance (Triumph Resin Dam) |
|---|---|
| Intended Use | Resin barrier used to isolate and protect dental materials and tissues. (Matches Opal Dam) |
| Composition | Urethane acrylates, silica, titanium dioxide, light curing chemistry. (Different from Opal Dam's Di-urethane di-methacrylate, filler. However, the document states "Formula differences...exist, however Triumph Resin Dam was found to be biocompatible...and has similar technological and performance characteristics.") |
| Light Cure Capability | Yes (Matches Opal Dam) |
| Light Cure Setting Time | Yes, |
§ 872.6300 Rubber dam and accessories.
(a)
Identification. A rubber dam and accessories is a device composed of a thin sheet of latex with a hole in the center intended to isolate a tooth from fluids in the mouth during dental procedures, such as filling a cavity preparation. The device is stretched around a tooth by inserting a tooth through a hole in the center. The device includes the rubber dam, rubber dam clamp, rubber dam frame, and forceps for a rubber dam clamp. This classification does not include devices intended for use in preventing transmission of sexually transmitted diseases through oral sex; those devices are classified as condoms in § 884.5300 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.