Cleared Traditional

K920758 - JENKER NEEDLE STICK PROTECTOR

K920758 is an FDA 510(k) clearance for JENKER NEEDLE STICK PROTECTOR, manufactured by Dentsply Intl.. The device is a Class 1 Dental device with product code DZM cleared through the Traditional 510(k) pathway after a 69-day FDA review.

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

K920758 is an FDA 510(k) clearance for the JENKER NEEDLE STICK PROTECTOR. Classified as Needle, Dental (product code DZM), Class I - General Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on April 28, 1992 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4730 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dentsply Intl. devices

FDA 510(k) Submission Details - K920758

510(k) Number K920758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 127d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

DZM Device Classification - Class 1, General Controls

Product Code DZM Needle, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4730
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DZM Needle, Dental

All 7
Devices cleared under the same product code (DZM) and FDA review panel - the closest regulatory comparables to K920758.
X-TIP INTRAOSSEOUS PERFORATOR
K990511 · Schiff & Co. · Apr 1999
SAFETY PLUS DENTAL INJECTION NEEDLE
K913573 · Specialites Septodont · Nov 1991
DENTAL NEEDLE (CARTRIDGE TYPE)
K870921 · Churchill Corp. · Apr 1987
TERUMO DENTAL NEEDLES
K864970 · Terumo Medical Corp. · Mar 1987
EXEL DENTAL NEEDLE
K861150 · Exel Intl. · Apr 1986
SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE
K851524 · Specialites Septodont · Sep 1985