(58 days)
PULPDENT PUTTY DAM is a light-cured resin used by the dental professional during bleaching, air abrasion and etching procedures. PULPDENT PUTTY DAM protects soft tissue by creating a physical barrier.
PULPDENT PUTTY DAM is a light-cured resin used by the dental professional during bleaching, air abrasion and etching procedures. PULPDENT PUTTY DAM protects soft tissue by creating a physical barrier.
The provided text is a 510(k) Premarket Notification for a dental device called "Pulpdent Putty Dam." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and a study proving the device meets those criteria in the way a clinical trial for an AI/ML medical device would.
Therefore, many of the requested categories are not applicable to this document. I will fill in the available information and explain why other sections are not present.
Acceptance Criteria and Device Performance Study for Pulpdent Putty Dam
This 510(k) Premarket Notification for Pulpdent Putty Dam primarily establishes substantial equivalence to predicate devices, rather than presenting a performance study against specific, quantified acceptance criteria. The claim of safety and effectiveness rests on the general usage history of similar materials and regulatory approvals of predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance |
|---|---|---|
| Safety | No short-term or long-term risks | "General usage of these materials over about 10 years indicates a high benefit-to-risk ratio. There is no evidence of short-term or long-term risk or suspicion of any problems." |
| Effectiveness/Intended Use | Protection of soft tissue by creating a physical barrier during bleaching, air abrasion, and etching procedures. | "PULPDENT PUTTY DAM protects soft tissue by creating a physical barrier." (Based on comparison to predicate devices with over 10 years of general usage demonstrating safety and effectiveness.) |
| Substantial Equivalence | Equivalent in composition and intended use to predicate devices | "PULPDENT PUTTY DAM is substantially equivalent in composition and intended use to the products listed above." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This submission does not describe a test set or a study with a specific sample size. The safety and effectiveness claims are based on:
- General usage history of similar materials (predicate devices) over approximately 10 years.
- The fact that predicate products have received 510(k) Premarket approval.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. There was no specific test set requiring ground truth established by experts. The document mentions "The safety and effectiveness of these resins is supported by the editors of Reality. 2002." While "Reality" is a dental product review publication, this is not a formal ground truth establishment process for a specific test set.
4. Adjudication Method for the Test Set
Not applicable, as no test set requiring adjudication was described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This type of study is typically performed for diagnostic devices where human readers interpret results, often with and without AI assistance. The Pulpdent Putty Dam is a physical barrier material, not an interpretative diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical dental material, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth," in the context of this 510(k), is implicitly based on the established safety record and performance of the predicate devices in clinical use over time. It relies on:
- Expert Consensus/Clinical Experience: "General usage of these materials over about 10 years indicates a high benefit-to-risk ratio."
- Regulatory Precedent: The predicate devices having received 510(k) approvals and being classified as Class I Dental Devices.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is not an AI/ML algorithm requiring ground truth establishment for a training set.
§ 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.