Cleared Traditional

K894373 - NIPRO DENTAL NEEDLE

K894373 is an FDA 510(k) clearance for NIPRO DENTAL NEEDLE, manufactured by Pharma-Plast USA, Inc.. The device is a Class 1 Dental device with product code DZM cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K894373 · Pharma-Plast USA, Inc. · Dental device
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Oct 1989
Decision
88d
Days
Class 1
Risk

K894373 is an FDA 510(k) clearance for the NIPRO DENTAL NEEDLE. Classified as Needle, Dental (product code DZM), Class I - General Controls.

Submitted by Pharma-Plast USA, Inc. (Clearwater, US). The FDA issued a Cleared decision on October 13, 1989 after a review of 88 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 Pharma-Plast USA, Inc. devices

FDA 510(k) Submission Details - K894373

510(k) Number K894373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1989
Decision Date October 13, 1989
Days to Decision 88 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 127d · This submission: 88d
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 8
Devices cleared under the same product code (DZM) and FDA review panel - the closest regulatory comparables to K894373.
X-TIP INTRAOSSEOUS PERFORATOR
K990511 · Schiff & Co. · Apr 1999
JENKER NEEDLE STICK PROTECTOR
K920758 · Dentsply Intl. · Apr 1992
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