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FDA 510(k)

CALCIUM HYDROXIDE MEDICAMENT

K-Number: K964191 · 1997-01-22

ApplicantSybron Dental Specialties, Inc.
Decision Date1997-01-22
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CALCIUM HYDROXIDE MEDICAMENT is the device name listed in this FDA 510(k) record. The listed applicant is Sybron Dental Specialties, Inc.. It received FDA 510(k) clearance on 1997-01-22 under 510(k) number K964191. 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 MEDICAMENT?

CALCIUM HYDROXIDE MEDICAMENT is a medical device that received FDA 510(k) clearance on 1997-01-22. The listed applicant is Sybron Dental Specialties, Inc.. The 510(k) number is K964191.

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

CALCIUM HYDROXIDE MEDICAMENT received FDA 510(k) clearance on 1997-01-22, under 510(k) number K964191.

Who is the listed applicant for CALCIUM HYDROXIDE MEDICAMENT?

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

What is the FDA product code for CALCIUM HYDROXIDE MEDICAMENT?

The FDA product code for CALCIUM HYDROXIDE MEDICAMENT 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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