Cleared Traditional

K896890 - DYNASURG DENTAL IRRIGATION SYSTEM

K896890 is an FDA 510(k) clearance for DYNASURG DENTAL IRRIGATION SYSTEM, manufactured by Micro Motors, Inc.. The device is a Class 1 Dental device with product code EFS cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K896890 · Micro Motors, Inc. · Dental device
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Feb 1990
Decision
68d
Days
Class 1
Risk

K896890 is an FDA 510(k) clearance for the DYNASURG DENTAL IRRIGATION SYSTEM. Classified as Unit, Oral Irrigation (product code EFS), Class I - General Controls.

Submitted by Micro Motors, Inc. (Santa Ana, US). The FDA issued a Cleared decision on February 14, 1990 after a review of 68 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 - K896890

510(k) Number K896890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1989
Decision Date February 14, 1990
Days to Decision 68 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 128d · This submission: 68d
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 26
Devices cleared under the same product code (EFS) and FDA review panel - the closest regulatory comparables to K896890.
WATER PIK(R) W/ADD'L CLAIMS
K900547 · Teledyne Water Pik · Jun 1990
ELECTRIC MOTOR W/PHYSIO DISPENSER, HANDPIECES
K900178 · Core-Vent Corp. · May 1990
SUNPAK AQUA FLOSS 2000 CORDLESS PERSONAL ORAL JET
K900991 · Tocad America, Inc. · May 1990
PIK POCKET(R), MODEL PP-3
K895259 · Teledyne Water Pik · Nov 1989
WATER PIK(R)
K894015 · Teledyne Water Pik · Aug 1989
PERIODONTAL SCALING SOLUTION-A
K875132 · Dentsply Intl. · Feb 1988
K896890 · DYNASURG DENTAL IRRIGATION SYSTEM
Download PDF Micro Motors, Inc.