Who is the manufacturer of 3M PROPLUS SYSTEM?

3M Company filed the 510(k) submission for 3M PROPLUS SYSTEM (K963766).

What is the FDA product code for 3M PROPLUS SYSTEM?

ELW. It is classified under 21 CFR 872.3660 as a Class 2 device in the Dental panel.

What is the regulatory pathway for 3M PROPLUS SYSTEM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like 3M PROPLUS SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

3M PROPLUS SYSTEM

K963766 · 3M Company · ELW · Oct 31, 1996 · Dental

Device Facts

Record ID	K963766
Device Name	3M PROPLUS SYSTEM
Applicant	3M Company
Product Code	ELW · Dental
Decision Date	Oct 31, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3660
Device Class	Class 2

Intended Use

3M™ ProPlus System is designed for making precise crown and bridge and denture impressions.

Device Story

Hydrophilic vinyl polysiloxane dental impression material system; consists of tray material and two wash materials of varying viscosities. Base and catalyst components extruded from two-part cartridges via mixing tip; material inserted into patient mouth; cures into rigid dental impression. Used by dental professionals for heavy body/light body impression techniques; tray material compatible with 3M Imprint monophase materials. Output is a physical dental impression used for crown, bridge, and denture fabrication.

Clinical Evidence

Bench testing only. Comparative tests performed on strain in compression, compression set, mixed consistency, and linear dimensional change.

Technological Characteristics

Hydrophilic vinyl polysiloxane addition cure chemistry. Two-part cartridge delivery system with mixing tip. Material cures to rigid state. No electronic or software components.

Indications for Use

Indicated for use in dental procedures requiring precise impressions for crowns, bridges, and dentures.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (Special Controls).

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)

Related Devices

K021413 — AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL · Dentsply Intl. · May 10, 2002
K021416 — AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL · Dentsply Intl. · May 13, 2002
K110092 — TAKE 1 ADVANCED RIGID TRAY · Kerr Corporation · Apr 8, 2011
K013140 — RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL · Rhodia, Inc. · Oct 10, 2001
K021410 — AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL · Dentsply Intl. · May 8, 2002

Submission Summary (Full Text)

{0} 3M Dental Products Laboratory 3M Center, Building 260-2B-09 St. Paul, MN 55144-1000 612 733 3149 K963766 OCT 31 1996 # 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. 3M™ 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.