Cleared Traditional

K926121 - BRASS NICK IMPRES TRAY/AMALGAM CAR/SYRI...

K926121 is an FDA 510(k) clearance for BRASS NICK IMPRES TRAY/AMALGAM CAR/SYRI..., manufactured by Dentmed , Ltd.. The device is a Class 2 Dental device with product code EJI cleared through the Traditional 510(k) pathway after a 427-day FDA review.

K926121 · Dentmed , Ltd. · Dental device
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Feb 1994
Decision
427d
Days
Class 2
Risk

K926121 is an FDA 510(k) clearance for the BRASS NICK IMPRES TRAY/AMALGAM CAR/SYRIN CART/ARTI. Classified as Syringe, Cartridge (product code EJI), Class II - Special Controls.

Submitted by Dentmed , Ltd. (Alexandria, US). The FDA issued a Cleared decision on February 3, 1994 after a review of 427 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6770 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Dentmed , Ltd. devices

FDA 510(k) Submission Details - K926121

510(k) Number K926121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1992
Decision Date February 03, 1994
Days to Decision 427 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
300d slower than avg
Panel avg: 127d · This submission: 427d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJI Device Classification - Class 2, Special Controls

Product Code EJI Syringe, Cartridge
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6770
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EJI Syringe, Cartridge

All 7
Devices cleared under the same product code (EJI) and FDA review panel - the closest regulatory comparables to K926121.
COMFORT CONTROL SYRINGE SYSTEM
K002387 · Dentsply Intl. · Sep 2000
EAGLE
K950309 · Aalba Dent, Inc. · Feb 1995
IMPULSE SEALER PRODUCT LINE
K943370 · Ultradent Products, Inc. · Oct 1994
CITOJECT CARTRIDGE SYRINGE
K842006 · Miles Laboratories, Inc. · Jul 1984
MULTI-PURPOSE DENTAL SYRINGE
K811831 · Centrix, Inc. · Sep 1981
MONOJECT PLASTIC DENTAL INJ. SYRINGE
K792541 · Sherwood Medical Co. · Feb 1980