Cleared Traditional

K963766 - 3M PROPLUS SYSTEM

K963766 is an FDA 510(k) clearance for 3M PROPLUS SYSTEM, manufactured by 3M Company. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K963766 · 3M Company · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
42d
Days
Class 2
Risk

K963766 is an FDA 510(k) clearance for the 3M PROPLUS SYSTEM. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on October 31, 1996 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all 3M Company devices

FDA 510(k) Submission Details - K963766

510(k) Number K963766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1996
Decision Date October 31, 1996
Days to Decision 42 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 127d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELW Material, Impression

All 306
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K963766.
KROMALGIN IMPRESSION MATERIAL
K964177 · North American Orthodontic Laboratories, Inc. · Dec 1996
CHROMOPRINT CHROMATIC ALGINATE IMPRESSION MATERIAL
K964323 · Fen Dental Mfg., Inc. · Dec 1996
PHASE PLUS
K963609 · Zhermack S.P.A. · Nov 1996
ALGINMAX, ORTHOCHROME
K963205 · American Tooth Industries · Oct 1996
HYUNJAE DENTAL IMPRESSION MATERIALS
K962680 · Hyunjae Corp. · Sep 1996
TRI-PHASIX CHROMATIC ALGINATE
K962741 · Parkell, Inc. · Sep 1996