(42 days)
No
The device description and intended use clearly describe a traditional dental impression material system, and there are no mentions of AI, ML, or image processing.
No
The device is used for making dental impressions, which are diagnostic tools, not therapeutic interventions. It does not treat or cure any medical condition.
No
The device is designed for making dental impressions for crowns, bridges, and dentures. Its purpose is to create a physical mold of the mouth, not to diagnose a medical condition.
No
The device description explicitly states the system is composed of "three hydrophilic vinyl polysiloxane dental impression materials" which are physical substances, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for making dental impressions for crowns, bridges, and dentures. This is a physical process of creating a mold of the mouth.
- Device Description: The device is a material that cures into a rigid impression. It's used to capture the physical shape of the teeth and gums.
- Lack of Diagnostic Purpose: IVDs are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device does not analyze any biological specimens. It's a tool for creating a physical replica.
The device is a dental impression material, which falls under the category of medical devices used in dentistry, but not specifically as an in vitro diagnostic.
N/A
Intended Use / Indications for Use
3M™ ProPlus System, like the predicate devices, is designed for making precise crown and bridge and denture impressions.
Product codes
Not Found
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The document describes "comparative results of the bench tests conducted. These tests include strain in compression, compression set, mixed consistency, and linear dimensional change." It concludes that the device "is safe, effective, and performs as well or better than the predicate devices."
Key Metrics
Not Found
Predicate Device(s)
3M™ Imprint™ Vinyl Polysiloxane Impression Material Single Phase System (K882690), Caulk®/Dentsply® Reprosil® Cartridge System (K863287), Kerr® Extrude™ Polyvinylsiloxane Impression Material System (K940379), Examix™ Hydrophilic Vinyl Polysiloxane Impression Material (K880849)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 Single |
| Phase 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.