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FDA 510(k)

CALCIUM HYDROXIDE PASTE

K-Number: K943372 · 1994-09-19

ApplicantUltradent Products, Inc.
Decision Date1994-09-19
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CALCIUM HYDROXIDE PASTE 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 1994-09-19 under 510(k) number K943372. The device is classified under product code EJK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CALCIUM HYDROXIDE PASTE?

CALCIUM HYDROXIDE PASTE is a medical device that received FDA 510(k) clearance on 1994-09-19. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K943372.

When did CALCIUM HYDROXIDE PASTE receive FDA 510(k) clearance?

CALCIUM HYDROXIDE PASTE received FDA 510(k) clearance on 1994-09-19, under 510(k) number K943372.

Who is the listed applicant for CALCIUM HYDROXIDE PASTE?

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 CALCIUM HYDROXIDE PASTE?

The FDA product code for CALCIUM HYDROXIDE PASTE is EJK.

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Related Devices (Code: EJK)

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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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