Cleared Traditional

K002753 - SPARTAN A-10

K002753 is an FDA 510(k) clearance for SPARTAN A-10, manufactured by Spartan Ultrasonics, Inc.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K002753 · Spartan Ultrasonics, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
90d
Days
Class 2
Risk

K002753 is an FDA 510(k) clearance for the SPARTAN A-10. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Spartan Ultrasonics, Inc. (Fenton, US). The FDA issued a Cleared decision on December 4, 2000 after a review of 90 days - within the typical 510(k) review window.

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 - K002753

510(k) Number K002753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2000
Decision Date December 04, 2000
Days to Decision 90 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: 128d · This submission: 90d
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 K002753.
PREMIER ULTRASONIC SCALER AND INSERTS
K010195 · Premier Dental Products Co. · Apr 2001
VECTOR
K002122 · Air Techniques, Inc. · Dec 2000
TKD SCALERS
K000846 · Orasystems · Dec 2000
SPARTAN MTS
K002521 · Spartan Marketing Group · Nov 2000
ART-M1, MODEL M1-1-ART-A1
K000510 · Bonart Co., Ltd. · May 2000
ART-M3 25K, MODEL M3-1-ART2-A1
K994203 · Bonart Co., Ltd. · Mar 2000
K002753 · SPARTAN A-10
Download PDF FDA Summary Spartan Ultrasonics, …