Cleared Traditional

K832949 - SANODENT DOUBLE-ENDED INTERDENTAL CLEAN

K832949 is an FDA 510(k) clearance for SANODENT DOUBLE-ENDED INTERDENTAL CLEAN, manufactured by Coopercare, Inc.. The device is a Class 1 Dental device with product code JET cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K832949 · Coopercare, Inc. · Dental device
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Oct 1983
Decision
32d
Days
Class 1
Risk

K832949 is an FDA 510(k) clearance for the SANODENT DOUBLE-ENDED INTERDENTAL CLEAN. Classified as Pick, Massaging (product code JET), Class I - General Controls.

Submitted by Coopercare, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 4, 1983 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6650 - 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 Coopercare, Inc. devices

FDA 510(k) Submission Details - K832949

510(k) Number K832949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1983
Decision Date October 04, 1983
Days to Decision 32 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 128d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

JET Device Classification - Class 1, General Controls

Product Code JET Pick, Massaging
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6650
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.