Cleared Traditional

K911701 - G-FLOSS & G-FLOSS II

K911701 is an FDA 510(k) clearance for G-FLOSS & G-FLOSS II, manufactured by Implant Innovations International, Inc.. The device is a Class 1 Dental device with product code JES cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K911701 · Implant Innovations International, Inc. · Dental device
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May 1991
Decision
29d
Days
Class 1
Risk

K911701 is an FDA 510(k) clearance for the G-FLOSS & G-FLOSS II. Classified as Floss, Dental (product code JES), Class I - General Controls.

Submitted by Implant Innovations International, Inc. (West Palm Beach, US). The FDA issued a Cleared decision on May 15, 1991 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6390 - 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 Implant Innovations International, Inc. devices

FDA 510(k) Submission Details - K911701

510(k) Number K911701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1991
Decision Date May 15, 1991
Days to Decision 29 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
98d faster than avg
Panel avg: 127d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

JES Device Classification - Class 1, General Controls

Product Code JES Floss, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6390
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.