Cleared Traditional

SAF (SELF ADJUSTING FILE)

K092933 · Redent-Nova , Ltd. · Dental
Jan 2010
Decision
113d
Days
Class 1
Risk

About This 510(k) Submission

K092933 is an FDA 510(k) clearance for the SAF (SELF ADJUSTING FILE), a Handpiece, Air-powered, Dental (Class I — General Controls, product code EFB), submitted by Redent-Nova , Ltd. (Washington, US). The FDA issued a Cleared decision on January 14, 2010, 113 days after receiving the submission on September 23, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K092933 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 2009
Decision Date January 14, 2010
Days to Decision 113 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EFB — Handpiece, Air-powered, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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