Cleared Traditional

K981325 - 3M M.G. MATERIAL

K981325 is an FDA 510(k) clearance for 3M M.G. MATERIAL, 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 59-day FDA review.

K981325 · 3M Company · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
59d
Days
Class 2
Risk

K981325 is an FDA 510(k) clearance for the 3M M.G. MATERIAL. 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 June 11, 1998 after a review of 59 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 - K981325

510(k) Number K981325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1998
Decision Date June 11, 1998
Days to Decision 59 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
68d faster than avg
Panel avg: 127d · This submission: 59d
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 K981325.
1ST IMPRESSION
K983106 · Den-Mat Corp. · Feb 1999
B-SYSTEM SILICONE
K982917 · Sybron Dental Specialties, Inc. · Oct 1998
ALGETRAL, CAVEX CHROMATIC, CA 37 SUPERIOR PINK, CA 37 FAST SET, CAVEX RAINBOW, CAVEX IMPRESSIONAL NORMAL SETTING, CAVEXI
K981970 · Cavex Holland BV · Sep 1998
LONE STAR IMPRESSION SYSTEMS
K980968 · Lone Star Technologies · Jun 1998
NEOCOLLOID, ORTHOPRINT
K981091 · Zhermack S.P.A. · May 1998
HONIGUM AUTOMIX IMPRESSION MATERIAL (FOIL BAGS) AND HONIGUM QUICK IMPRESSION MATERIAL (CARTRIDGES)
K980963 · Foremost Dental Mfg., Inc. · May 1998