Cleared Traditional

K972006 - ACTA OEM MODULE

K972006 is an FDA 510(k) clearance for ACTA OEM MODULE, manufactured by Interactive Consulting, Inc.. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K972006 · Interactive Consulting, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
41d
Days
Class 2
Risk

K972006 is an FDA 510(k) clearance for the ACTA OEM MODULE. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Interactive Consulting, Inc. (Wellesley, US). The FDA issued a Cleared decision on July 10, 1997 after a review of 41 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 Interactive Consulting, Inc. devices

FDA 510(k) Submission Details - K972006

510(k) Number K972006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1997
Decision Date July 10, 1997
Days to Decision 41 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
86d faster than avg
Panel avg: 127d · This submission: 41d
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 103
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K972006.
AIRDENT RADIANCE CURING LIGHT
K982615 · Air Techniques, Inc. · Aug 1998
APOLLO 9500
K974369 · Ion Laser Technology · Jan 1998
3M AURORA SYSTEM
K972355 · 3M Company · Aug 1997
HILUX 200,250,275,300,350,500 DENTAL CURING LIGHT
K970506 · Benlioglu Dental Ithalat, Inc. · Jun 1997
ILT ARGON HP
K964524 · Ion Laser Technology · Mar 1997
JETLITE
K963110 · J. Morita USA, Inc. · Oct 1996