510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K943370Substantially Equivalent

Impulse Sealer Product Line

Ultradent Products Inc., South Jordan UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943370 is the FDA 510(k) clearance record for IMPULSE SEALER PRODUCT LINE, a class II device, cleared for Ultradent Products, Inc. on under FDA product code EJI (Syringe, Cartridge). FDA records list 104 510(k) clearances for Ultradent Products, Inc., from to . As of , FDA records show no recalls naming K943370.

Clearance record

Decision date
Received
(100 days to decision)
Product code
EJI Syringe, Cartridge
Regulation
21 CFR 872.6770
Device class
Class II
Review panel
Dental
Applicant
Ultradent Products, Inc. 505 W. 10200 So., South Jordan UT
510(k) summary
Statement
Third party review
No

Clearances, product code EJI

Trailing 12 months

FDA records hold no clearances under product code EJI in the trailing twelve months.

FDA records show no clearances under product code EJI in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EJI, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260