Cleared Traditional

K983374 - AGATHA-A-H2010

K983374 is an FDA 510(k) clearance for AGATHA-A-H2010, manufactured by Midian Intl.. The device is a Class 1 Dental device with product code EFS cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K983374 · Midian Intl. · Dental device
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Dec 1998
Decision
89d
Days
Class 1
Risk

K983374 is an FDA 510(k) clearance for the AGATHA-A-H2010. Classified as Unit, Oral Irrigation (product code EFS), Class I - General Controls.

Submitted by Midian Intl. (Lauderhill, US). The FDA issued a Cleared decision on December 23, 1998 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6510 - 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.

FDA 510(k) Submission Details - K983374

510(k) Number K983374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1998
Decision Date December 23, 1998
Days to Decision 89 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
39d faster than avg
Panel avg: 128d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

EFS Device Classification - Class 1, General Controls

Product Code EFS Unit, Oral Irrigation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6510
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EFS Unit, Oral Irrigation

All 41
Devices cleared under the same product code (EFS) and FDA review panel - the closest regulatory comparables to K983374.
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K983374 · AGATHA-A-H2010
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