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FDA 510(k)

IMPULSE SEALER PRODUCT LINE

K-Number: K943370 · 1994-10-21

ApplicantUltradent Products, Inc.
Decision Date1994-10-21
Product CodeEJI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IMPULSE SEALER PRODUCT LINE is the device name listed in this FDA 510(k) record. The listed applicant is Ultradent Products, Inc.. It received FDA 510(k) clearance on 1994-10-21 under 510(k) number K943370. The device is classified under product code EJI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPULSE SEALER PRODUCT LINE?

IMPULSE SEALER PRODUCT LINE is a medical device that received FDA 510(k) clearance on 1994-10-21. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K943370.

When did IMPULSE SEALER PRODUCT LINE receive FDA 510(k) clearance?

IMPULSE SEALER PRODUCT LINE received FDA 510(k) clearance on 1994-10-21, under 510(k) number K943370.

Who is the listed applicant for IMPULSE SEALER PRODUCT LINE?

The FDA 510(k) record lists Ultradent Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMPULSE SEALER PRODUCT LINE?

The FDA product code for IMPULSE SEALER PRODUCT LINE is EJI.

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Related Devices (Code: EJI)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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