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FDA 510(k)

BASIC CALCIUM HYDROXIDE LINER

K-Number: K896529 · 1990-01-16

ApplicantIvoclar North America, Inc.
Decision Date1990-01-16
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BASIC CALCIUM HYDROXIDE LINER is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar North America, Inc.. It received FDA 510(k) clearance on 1990-01-16 under 510(k) number K896529. 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 BASIC CALCIUM HYDROXIDE LINER?

BASIC CALCIUM HYDROXIDE LINER is a medical device that received FDA 510(k) clearance on 1990-01-16. The listed applicant is Ivoclar North America, Inc.. The 510(k) number is K896529.

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

BASIC CALCIUM HYDROXIDE LINER received FDA 510(k) clearance on 1990-01-16, under 510(k) number K896529.

Who is the listed applicant for BASIC CALCIUM HYDROXIDE LINER?

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

What is the FDA product code for BASIC CALCIUM HYDROXIDE LINER?

The FDA product code for BASIC CALCIUM HYDROXIDE LINER is EJK.

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Other records listing Ivoclar North America, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: EJK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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