Cleared Traditional

K961735 - ACTA

K961735 is an FDA 510(k) clearance for ACTA, manufactured by Satelec. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K961735 · Satelec · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
89d
Days
Class 2
Risk

K961735 is an FDA 510(k) clearance for the ACTA. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Satelec (Wellesley, US). The FDA issued a Cleared decision on July 31, 1996 after a review of 89 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 Satelec devices

FDA 510(k) Submission Details - K961735

510(k) Number K961735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1996
Decision Date July 31, 1996
Days to Decision 89 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
38d faster than avg
Panel avg: 127d · This submission: 89d
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 88
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K961735.
ELIPAR TRILIGHT
K984247 · Espe Dental AG · Feb 1999
3M AURORA SYSTEM
K972355 · 3M Company · Aug 1997
JETLITE
K963110 · J. Morita USA, Inc. · Oct 1996
SPECTRUM CURING LIGHT POLYMERIZATION UNIT
K951425 · Dentsply Intl. · May 1995
3M CURING LIGHT XL1500
K934746 · 3M Company · Jan 1994
ORTHOLUX XT
K930086 · 3M Company · Apr 1993