(59 days)
DENU Light Body(Regular, Fast) / DENU Heavy Body(Regular, Fast)
- Crown and bridge impression
- Inlay and onlay impression
- Denture impression
- Model impression
DENU Putty Set(Regular, Fast)
- Crown and bridge impression
- Inlay and onlay impression
The DENU family of silicone impression materials consists of three different viscosities (light body, heavy body, putty) for various application systems. Products are further classified into Regular type and Fast type, depending on curing time, but there is no difference on viscosity, indications for use, or scope of use. Each device is consisted of 1:1 base and catalyst component, packaged in 560mL jars for DENU Putty set and 50mL syringes for other devices.
This is a 510(k) premarket notification for a dental impression material, DENU Light Body (Regular, Fast), DENU Heavy Body (Regular, Fast), and DENU Putty Set (Regular, Fast). The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and supporting study information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily derived from the international standard ISO 4823:2021 (Dentistry - Elastomeric impression materials) and the device's performance is compared to these standards and the predicate devices.
| Performance Characteristic | Acceptance Criteria (from ISO 4823:2021 or Predicate) | DENU Light Body (Regular, Fast) Reported Performance | DENU Heavy Body (Regular, Fast) Reported Performance | DENU Putty Set (Regular, Fast) Reported Performance | Performance Conclusion |
|---|---|---|---|---|---|
| Working Time | Specified by manufacturer or within predicate's range (e.g., 1'30" - 2'30" for light body) | Light Body, Regular: 1'30" | Heavy Body, Regular: 1'30" | Putty Set Regular: 1'30" | Equivalent / Similar (conforms to standard) |
| Light Body, Fast: 1'30" | Heavy Body, Fast: 1'30" | Putty Set Fast: 1'30" | Equivalent / Similar (conforms to standard) | ||
| Setting Reaction Time | Specified by manufacturer or within predicate's range (e.g., 2'30" - 4'00" for light body) | Light Body, Regular: 4'10" | Heavy Body, Regular: 4'10" | Not directly reported (comparison to predicate shows equivalence) | Equivalent |
| Light Body, Fast: 2'40" | Heavy Body, Fast: 2'40" | Equivalent | |||
| Consistency / Flow | Light Body: >= 36 mm (ISO 4823:2021 7.2) | Light Body, Regular: 39.18 mm | Equivalent | ||
| Light Body, Fast: 36.16 mm | Equivalent | ||||
| Heavy Body: |
§ 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).