Cleared Traditional

FORCE II

K895163 · American Orthodontics · Dental
Oct 1989
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K895163 is an FDA 510(k) clearance for the FORCE II, a Adhesive, Bracket And Tooth Conditioner, Resin (Class II — Special Controls, product code DYH), submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on October 27, 1989, 66 days after receiving the submission on August 22, 1989. This device falls under the Dental review panel. Regulated under 21 CFR 872.3750.

Submission Details

510(k) Number K895163 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 1989
Decision Date October 27, 1989
Days to Decision 66 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code DYH — Adhesive, Bracket And Tooth Conditioner, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3750

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