Cleared Traditional

K904278 - HOLDER, DENTAL BUR, ALUMINUM

K904278 is an FDA 510(k) clearance for HOLDER, manufactured by Maverick Surgical, Inc.. The device is a Class 2 Dental device with product code EJI cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K904278 · Maverick Surgical, Inc. · Dental device
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Nov 1990
Decision
46d
Days
Class 2
Risk

K904278 is an FDA 510(k) clearance for the HOLDER, DENTAL BUR, ALUMINUM. Classified as Syringe, Cartridge (product code EJI), Class II - Special Controls.

Submitted by Maverick Surgical, Inc. (Edmonton, Alberta, CA). The FDA issued a Cleared decision on November 2, 1990 after a review of 46 days - a notably fast clearance cycle.

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: 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 Maverick Surgical, Inc. devices

FDA 510(k) Submission Details - K904278

510(k) Number K904278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1990
Decision Date November 02, 1990
Days to Decision 46 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 127d · This submission: 46d
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 25
Devices cleared under the same product code (EJI) and FDA review panel - the closest regulatory comparables to K904278.
DENTALOGIC
K960270 · Protecs Syringes International Corp. · Mar 1996
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
BEACH ANESTHETIC SYRINGE CARTR. TYPE
K821782 · Pacific Dental Corp. · Jul 1982
MULTI-PURPOSE DENTAL SYRINGE
K811831 · Centrix, Inc. · Sep 1981