Cleared Traditional

ORTHODONTIC COTTON ROLL HOLDERS

K891354 · American Orthodontics · Dental
Apr 1989
Decision
38d
Days
Class 1
Risk

About This 510(k) Submission

K891354 is an FDA 510(k) clearance for the ORTHODONTIC COTTON ROLL HOLDERS, a Absorber, Saliva, Paper (Class I — General Controls, product code KHR), submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on April 17, 1989, 38 days after receiving the submission on March 10, 1989. This device falls under the Dental review panel. Regulated under 21 CFR 872.6050.

Submission Details

510(k) Number K891354 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 1989
Decision Date April 17, 1989
Days to Decision 38 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code KHR — Absorber, Saliva, Paper
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6050