Cleared Traditional

K122748 - ENGLER 25K SERIES ULTRASONIC INSERTS

K122748 is an FDA 510(k) clearance for ENGLER 25K SERIES ULTRASONIC INSERTS, manufactured by Engler Engineering Corp.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 277-day FDA review.

K122748 · Engler Engineering Corp. · Dental device
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Jun 2013
Decision
277d
Days
Class 2
Risk

K122748 is an FDA 510(k) clearance for the ENGLER 25K SERIES ULTRASONIC INSERTS. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Engler Engineering Corp. (Hialeah, US). The FDA issued a Cleared decision on June 11, 2013 after a review of 277 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.

FDA 510(k) Submission Details - K122748

510(k) Number K122748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2012
Decision Date June 11, 2013
Days to Decision 277 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
149d slower than avg
Panel avg: 128d · This submission: 277d
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 164
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K122748.
BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER
K130137 · Coltene/Whaledent · Aug 2013
AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM
K130693 · Aseptico, Inc. · Aug 2013
CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM
K130862 · Dentsply Intl., Inc. · Jul 2013
SONENDO ENDOTHERAPY SYSTEM
K130025 · Sonendo, Inc. · Jun 2013
AEI DR. TERAUCHI ULTRASONIC TIPS
K122501 · American Eagle Instruments, Inc. · Mar 2013
ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES
K123139 · Asi Medical, Inc. · Mar 2013
K122748 · ENGLER 25K SERIES ULTRASONIC INSERTS
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