Cleared Traditional

K130834 - R7

K130834 is the FDA 510(k) clearance for R7 by Cefla S.C.. It is a Class 2 Dental device (product code ELC) cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K130834 · Cefla S.C. · Dental device
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Oct 2013
Decision
196d
Days
Class 2
Risk

K130834 is an FDA 510(k) clearance for the R7. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Cefla S.C. (Ormond Beach, US). The FDA issued a Cleared decision on October 8, 2013 after a review of 196 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 Cefla S.C. devices

Submission Details

510(k) Number K130834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2013
Decision Date October 08, 2013
Days to Decision 196 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 127d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 57
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K130834.
Sonendo GentleWave System
K190359 · Sonendo, Inc. · Mar 2019
AW-100
K171150 · Micron Corporation · Mar 2018
Cavitron Touch Ultrasonic Scaling System
K150535 · Dentsply International, Inc. · Jun 2015
ULTRASONIC SCALER
K113717 · Nakanishi, Inc. · Mar 2013
ULTRASONIC SCALER
K113530 · Nakanishi, Inc. · Jan 2013
A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM
K100647 · A-Dec, Inc. · Jul 2010