Cleared Traditional

K844250 - OSADA ENAC

K844250 is an FDA 510(k) clearance for OSADA ENAC, manufactured by Osada Electric Co., Ltd.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K844250 · Osada Electric Co., Ltd. · Dental device
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Jan 1985
Decision
82d
Days
Class 2
Risk

K844250 is an FDA 510(k) clearance for the OSADA ENAC. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Osada Electric Co., Ltd. (Los Angeles, US). The FDA issued a Cleared decision on January 23, 1985 after a review of 82 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Osada Electric Co., Ltd. devices

FDA 510(k) Submission Details - K844250

510(k) Number K844250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1984
Decision Date January 23, 1985
Days to Decision 82 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 127d · This submission: 82d
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 140
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K844250.
PERIODONTAL IRRIGATING SOLUTION-D
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ULTRASONIC SCALER 3000/ PROPHY-JET 30/ CAVI-JET 30
K864996 · Dentsply Intl. · Feb 1987
ULTRASONIC TOOTH SCALER MODEL DSCIOP
K852540 · Parkell, Inc. · Jul 1985
CAVI-MED
K842581 · Cooper Lasersonics, Inc. · Aug 1984
DENTAL ULTRASONIC SCALER/ENDOSONIC
K840141 · CooperVision, Inc. · Mar 1984
ROOT CANAL KIT
K811023 · Dentsply Intl. · May 1981