Cleared Traditional

JENKER NEEDLE STICK PROTECTOR

K920758 · Dentsply Intl. · Dental
Apr 1992
Decision
69d
Days
Class 1
Risk

About This 510(k) Submission

K920758 is an FDA 510(k) clearance for the JENKER NEEDLE STICK PROTECTOR, a Needle, Dental (Class I — General Controls, product code DZM), submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on April 28, 1992, 69 days after receiving the submission on February 19, 1992. This device falls under the Dental review panel. Regulated under 21 CFR 872.4730.

Submission Details

510(k) Number K920758 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 1992
Decision Date April 28, 1992
Days to Decision 69 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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