Cleared Traditional

K943370 - IMPULSE SEALER PRODUCT LINE

K943370 is the FDA 510(k) clearance for IMPULSE SEALER PRODUCT LINE by Ultradent Products, Inc.. It is a Class 2 Dental device (product code EJI) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K943370 · Ultradent Products, Inc. · Dental device
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Oct 1994
Decision
100d
Days
Class 2
Risk

K943370 is an FDA 510(k) clearance for the IMPULSE SEALER PRODUCT LINE. Classified as Syringe, Cartridge (product code EJI), Class II - Special Controls.

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on October 21, 1994 after a review of 100 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Ultradent Products, Inc. devices

Submission Details

510(k) Number K943370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1994
Decision Date October 21, 1994
Days to Decision 100 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
27d faster than avg
Panel avg: 127d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Devices cleared under the same product code (EJI) and FDA review panel - the closest regulatory comparables to K943370.
Miltex N-Tralig Intraligamentary Syringe
K142414 · Integra LifeSciences Corporation · Oct 2014
COMFORT CONTROL SYRINGE SYSTEM
K002387 · Dentsply Intl. · Sep 2000
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