Cleared Traditional

ORTHODONTIC COTTON ROLL HOLDERS (K891354) - FDA 510(k) Clearance

Class I Dental device.

K891354 · American Orthodontics · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1989
Decision
38d
Days
Class 1
Risk

K891354 is an FDA 510(k) clearance for the ORTHODONTIC COTTON ROLL HOLDERS. Classified as Absorber, Saliva, Paper (product code KHR), Class I - General Controls.

Submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on April 17, 1989 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6050 - 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 American Orthodontics devices

Submission Details

510(k) Number K891354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1989
Decision Date April 17, 1989
Days to Decision 38 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 127d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KHR Absorber, Saliva, Paper
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6050
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.