Cleared Traditional

K972355 - 3M AURORA SYSTEM

K972355 is an FDA 510(k) clearance for 3M AURORA SYSTEM, manufactured by 3M Company. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K972355 · 3M Company · Dental device
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Aug 1997
Decision
65d
Days
Class 2
Risk

K972355 is an FDA 510(k) clearance for the 3M AURORA SYSTEM. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on August 29, 1997 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6070 - 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 - K972355

510(k) Number K972355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1997
Decision Date August 29, 1997
Days to Decision 65 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 127d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBZ Device Classification - Class 2, Special Controls

Product Code EBZ Activator, Ultraviolet, For Polymerization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6070
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 - EBZ Activator, Ultraviolet, For Polymerization

All 141
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K972355.
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K970506 · Benlioglu Dental Ithalat, Inc. · Jun 1997
ILT ARGON HP
K964524 · Ion Laser Technology · Mar 1997