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FDA 510(k)

DENTIN BONDING SYSTEM

K-Number: K894994 · 1989-10-24

ApplicantCosmedent, Inc.
Decision Date1989-10-24
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTIN BONDING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cosmedent, Inc.. It received FDA 510(k) clearance on 1989-10-24 under 510(k) number K894994. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTIN BONDING SYSTEM?

DENTIN BONDING SYSTEM is a medical device that received FDA 510(k) clearance on 1989-10-24. The listed applicant is Cosmedent, Inc.. The 510(k) number is K894994.

When did DENTIN BONDING SYSTEM receive FDA 510(k) clearance?

DENTIN BONDING SYSTEM received FDA 510(k) clearance on 1989-10-24, under 510(k) number K894994.

Who is the listed applicant for DENTIN BONDING SYSTEM?

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

What is the FDA product code for DENTIN BONDING SYSTEM?

The FDA product code for DENTIN BONDING SYSTEM is KLE.

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Related Devices (Code: KLE)

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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