Cleared Traditional

K131151 - ENDOCENTER

K131151 is an FDA 510(k) clearance for ENDOCENTER, manufactured by Satelec - Acteon Group. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K131151 · Satelec - Acteon Group · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
268d
Days
Class 2
Risk

K131151 is an FDA 510(k) clearance for the ENDOCENTER. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Satelec - Acteon Group (Mt. Laurel, US). The FDA issued a Cleared decision on January 16, 2014 after a review of 268 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4850 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Satelec - Acteon Group devices

FDA 510(k) Submission Details - K131151

510(k) Number K131151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2013
Decision Date January 16, 2014
Days to Decision 268 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
140d slower than avg
Panel avg: 128d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELC Device Classification - Class 2, Special Controls

Product Code ELC Scaler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4850
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 - ELC Scaler, Ultrasonic

All 153
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K131151.
NEWTRON P5 XS B.LED
K132322 · Satelec - Acteon Group · Mar 2014
NEWTRON P5, NEWTRON P5 B.LED
K132267 · Satelec - Acteon Group · Mar 2014
EDS ULTRASONIC TIPS
K132609 · Essential Dental Systems, Inc. · Jan 2014
PIEZON 250
K132445 · E.M.S Electro Medical Systems S.A · Dec 2013
NEWTRON BOOSTER
K131997 · Satelec - Acteon Group · Nov 2013
PIEZON 150
K132443 · E.M.S Electro Medical Systems S.A · Nov 2013