Cleared Traditional

K803129 - GO-BETWEEN

K803129 is an FDA 510(k) clearance for GO-BETWEEN, manufactured by Agri Hort. The device is a Class 1 Dental device with product code JES cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K803129 · Agri Hort · Dental device
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Jan 1981
Decision
27d
Days
Class 1
Risk

K803129 is an FDA 510(k) clearance for the GO-BETWEEN. Classified as Floss, Dental (product code JES), Class I - General Controls.

Submitted by Agri Hort (Mchenry, US). The FDA issued a Cleared decision on January 8, 1981 after a review of 27 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 Agri Hort devices

FDA 510(k) Submission Details - K803129

510(k) Number K803129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1980
Decision Date January 08, 1981
Days to Decision 27 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 128d · This submission: 27d
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.