Cleared Traditional

ORTHO-KEV APPLIANCE REINFORCING SYSTEM

K895714 · American Orthodontics · Dental
Dec 1989
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K895714 is an FDA 510(k) clearance for the ORTHO-KEV APPLIANCE REINFORCING SYSTEM, a Resin, Denture, Relining, Repairing, Rebasing (Class II — Special Controls, product code EBI), submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on December 21, 1989, 87 days after receiving the submission on September 25, 1989. This device falls under the Dental review panel. Regulated under 21 CFR 872.3760.

Submission Details

510(k) Number K895714 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 1989
Decision Date December 21, 1989
Days to Decision 87 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EBI — Resin, Denture, Relining, Repairing, Rebasing
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3760

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