Cleared Traditional

SAFETY PLUS DENTAL INJECTION NEEDLE

K913573 · Specialites Septodont · Dental
Nov 1991
Decision
87d
Days
Class 1
Risk

About This 510(k) Submission

K913573 is an FDA 510(k) clearance for the SAFETY PLUS DENTAL INJECTION NEEDLE, a Needle, Dental (Class I — General Controls, product code DZM), submitted by Specialites Septodont (Washington, US). The FDA issued a Cleared decision on November 7, 1991, 87 days after receiving the submission on August 12, 1991. This device falls under the Dental review panel. Regulated under 21 CFR 872.4730.

Submission Details

510(k) Number K913573 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 1991
Decision Date November 07, 1991
Days to Decision 87 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code DZM — Needle, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4730

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