# K963766: 3M Proplus System

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Oct 31, 1996 after 42 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K863288 (1986). 4 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K882690: Imprint Vinyl Polysiloxane Impression Material, 3M Company (1988) Summary page 1.
- K863288: Hydrophilic Reprosil, Dentsply Intl. (1986). Our OCR of the scanned summary read K863287, FDA’s number for Uric Acid (Uricase) Method-II (Catachem, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Caulk®/Dentsply® Reprosil® Cartridge System”.
- K940379: Extrude, Sybron Dental Specialties, Inc. (1994) Summary page 1.
- K880849: Examix Dispenser, G-C Intl. Corp. (1988) Summary page 1.

## Most influential descendants
- K120438: Flash (Different Materials) (2012), 4 descendants of its own
- K131404: Flash AR Penta / Flash AR Penta Quick (2013), 2 descendants of its own
- K140602: Flash Penta MB Quick, Flash MB Quick (2014), 0 descendants of its own
- K133436: Flash AR; Flash AR Quick (2014), 0 descendants of its own
- K133400: Flash Bite (2014), 0 descendants of its own

## Indications for use
3M™ ProPlus System, like the predicate devices, is designed for making precise crown and bridge and denture impressions.

Source page: https://510kreport.com/device/K963766
Methodology: https://510kreport.com/methodology