(42 days)
3M™ ProPlus System, like the predicate devices, is designed for making precise crown and bridge and denture impressions.
3M™ ProPlus System is composed of three hydrophilic vinyl polysiloxane dental impression materials. The system includes a tray material and two wash materials with different viscosities. The base and catalyst are extruded from two-part cartridges through a mixing tip. The pastes are inserted into the mouth and they cure into a rigid dental impression. 3M™ ProPlus System tray and wash materials are specially formulated to meet the demands of the heavy body/light body impression technique. The tray material may also be used in combination with 3M Imprint™ monophase materials.
The provided text is a 510(k) summary for a dental impression material (3M™ ProPlus System), not an AI/ML device. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria, study data, sample sizes, expert qualifications, or ground truth for an AI/ML device.
The document describes the product, its intended use, and compares it to predicate devices using bench tests for material properties. It concludes that the device is safe and effective based on these bench tests and safety analysis.
No information regarding AI/ML device performance, acceptance criteria, or study details as outlined in the prompt can be extracted from this document.
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3M Dental Products Laboratory
3M Center, Building 260-2B-09 St. Paul. MN 55144-1000 612 733 3149
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR $807.92.
| Name: | Amy E. Fowler |
|---|---|
| Address: | 3M Dental Products Laboratory |
| 3M Center, Building 260-2B-09 | |
| St. Paul, MN 55144-1000 | |
| Phone: | (612) 736-1590 |
| Fax: | (612) 736-0990 |
| Date: | September 6, 1996 |
| Trade Name: | 3M™ ProPlus System |
| Common Names: | Dental impression material |
| Classification Name: | Impression material(21 CFR 872.3660) |
| Predicate devices: | 3M™ Imprint™ Vinyl Polysiloxane Impression Material SinglePhase System (K882690) |
| Caulk®/Dentsply® Reprosil® Cartridge System (K863287) | |
| Kerr® Extrude™ Polyvinylsiloxane Impression Material System(K940379) | |
| Examix™ Hydrophilic Vinyl Polysiloxane Impression Material(K880849) |
3M™ ProPlus System is composed of three hydrophilic vinyl polysiloxane dental impression materials. The system includes a tray material and two wash materials with different viscosities. The base and catalyst are extruded from two-part cartridges through a mixing tip. The pastes are inserted into the mouth and they cure into a rigid dental impression. 3M™ ProPlus System tray and wash materials are specially formulated to meet the demands of the heavy body/light body impression technique. The tray material may also be used in combination with 3M Imprint™ monophase materials.
3M™ ProPlus System, like the predicate devices, is designed for making precise crown and bridge and denture impressions.
3MTM ProPlus System and the predicate devices have similar technological characteristics as indicated by their vinyl polysiloxane addition cure chemistry. This is further validated by the comparative results of the bench tests conducted. These tests include strain in compression, compression set, mixed consistency, and linear dimensional change.
Based on the safety analysis and the bench tests, 3M™ ProPlus System is safe, effective, and performs as well or better than the predicate devices.
§ 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).