Cleared Traditional

K991888 - MINIJECT

K991888 is an FDA 510(k) clearance for MINIJECT, manufactured by Spartan Ultrasonics, Inc.. The device is a Class 2 Dental device with product code EJI cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K991888 · Spartan Ultrasonics, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
84d
Days
Class 2
Risk

K991888 is an FDA 510(k) clearance for the MINIJECT. Classified as Syringe, Cartridge (product code EJI), Class II - Special Controls.

Submitted by Spartan Ultrasonics, Inc. (Fenton, US). The FDA issued a Cleared decision on August 25, 1999 after a review of 84 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 Spartan Ultrasonics, Inc. devices

FDA 510(k) Submission Details - K991888

510(k) Number K991888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1999
Decision Date August 25, 1999
Days to Decision 84 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 127d · This submission: 84d
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 17
Devices cleared under the same product code (EJI) and FDA review panel - the closest regulatory comparables to K991888.
MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT
K083796 · Miltex, Inc. · Mar 2009
COMFORT CONTROL SYRINGE SYSTEM
K002387 · Dentsply Intl. · Sep 2000
WAND PLUS
K992819 · Spintech, Inc. · May 2000
CCS
K983105 · Dentsply Midwest · Mar 1999
GETTIG STYRL-JECT DELIVERY SYSTEM
K972285 · Gettig Pharmaceutical Instrument Co. · Sep 1997
SAFETY INJECTION SYSTEM
K962999 · Integritech, Inc. · Jan 1997