Cleared Traditional

ORTHODONITC ELASTOMERIC SLEEVING

K943421 · Jon-Ko Products, Inc. · Dental
May 1995
Decision
312d
Days
Class 1
Risk

About This 510(k) Submission

K943421 is an FDA 510(k) clearance for the ORTHODONITC ELASTOMERIC SLEEVING, a Tube, Orthodontic (Class I — General Controls, product code DZD), submitted by Jon-Ko Products, Inc. (San Diego, US). The FDA issued a Cleared decision on May 23, 1995, 312 days after receiving the submission on July 15, 1994. This device falls under the Dental review panel. Regulated under 21 CFR 872.5410.

Submission Details

510(k) Number K943421 FDA.gov
FDA Decision Cleared SESE
Date Received July 15, 1994
Decision Date May 23, 1995
Days to Decision 312 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code DZD — Tube, Orthodontic
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.5410