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Impulse Sealer Product Line

by Ultradent Products, Inc.

510(k) K943370

Impulse Sealer Product Line is a Class II device made by Ultradent Products, Inc., cleared under FDA 510(k) K943370 on 21 Oct 1994, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK943370 Date21 Oct 1994ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
EJI
Device class
Class II
Regulation
21 CFR Part 872.6770
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code EJI (Syringe, Cartridge).

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