Cleared Traditional

K943370 - IMPULSE SEALER PRODUCT LINE

K943370 is an FDA 510(k) clearance for IMPULSE SEALER PRODUCT LINE, manufactured by Ultradent Products, Inc.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K943370

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.

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 20
Devices cleared under the same product code (EJI) and FDA review panel - the closest regulatory comparables to K943370.
THE WAND
K961648 · Spintech, Inc. · Jul 1996
DENTALOGIC
K960270 · Protecs Syringes International Corp. · Mar 1996
EAGLE
K950309 · Aalba Dent, Inc. · Feb 1995
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