(126 days)
Used for all crown, bridge, and orthodontic impression techniques.
The Impression Material is a kind of addition-cure rubber impression material composed of vinyl polysiloxane and various fillers, with neutral smell and applicable to impression in dentistry. It consists of base and catalyst, in which putty base contains Vinyl polysiloxane, Methylhydrogensiloxane dimethylsiloxane, dimeticone, white oil and silicon. Catalyst mainly contains vinyl polysiloxane, platinum catalyst, dimeticone, white oil and silicon. The product is provided non-sterile.
Based on the provided text, the document is a 510(k) summary for a dental "Impression Material" and does not describe an AI/ML-based device. Therefore, many of the requested criteria (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies, human-in-the-loop performance, etc.) are not applicable to this submission.
The document discusses the substantial equivalence of the "Impression Material" to a predicate device based on non-clinical tests and material properties.
Here's an analysis of the provided information, noting where the requested criteria are not applicable:
1. A table of acceptance criteria and the reported device performance
The relevant information is in "Table 2 Performance parameter" on page 5.
| Item | Reported Device Performance (Proposed device) | Acceptance Criteria (Type 0) | Result |
|---|---|---|---|
| Consistency | 32 mm |
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).