Cleared Traditional

K053578 - SCORPION ULTRASONIC SCALING INSERTS

K053578 is an FDA 510(k) clearance for SCORPION ULTRASONIC SCALING INSERTS, manufactured by Scorpion. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K053578 · Scorpion · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
204d
Days
Class 2
Risk

K053578 is an FDA 510(k) clearance for the SCORPION ULTRASONIC SCALING INSERTS. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Scorpion (Deerfield, US). The FDA issued a Cleared decision on July 14, 2006 after a review of 204 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 - K053578

510(k) Number K053578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2005
Decision Date July 14, 2006
Days to Decision 204 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
76d slower than avg
Panel avg: 128d · This submission: 204d
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 175
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K053578.
USI DENTAL SCALER, 25XXX SERIES
K062791 · Ultrasonic Services, Inc. · Dec 2006
ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L
K053555 · Guilin Woodpecker Medical Instrument Co., Ltd. · Aug 2006
BONART ART-P3II & P4 PIEZO ELECTRIC ULTRASONIC SCALER UNITS WITH ACCESSORIES
K061448 · Bonart Co., Ltd. · Aug 2006
PIEZOTOME
K060275 · Satelec · May 2006
CLEANSE S+ ULTRASONIC SCALER
K060171 · Dmetec.Co., Ltd. · Mar 2006
SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPS
K053178 · Hu-Friedy Mfg. Co., Inc. · Feb 2006
K053578 · SCORPION ULTRASONIC SCALING INSERTS
Download PDF FDA Summary Scorpion