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FDA 510(k)

TOTAL ETCH BONDING AGENT

K-Number: K063444 · 2007-03-20

ApplicantDmg USA, Inc.
Decision Date2007-03-20
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TOTAL ETCH BONDING AGENT is the device name listed in this FDA 510(k) record. The listed applicant is Dmg USA, Inc.. It received FDA 510(k) clearance on 2007-03-20 under 510(k) number K063444. 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 TOTAL ETCH BONDING AGENT?

TOTAL ETCH BONDING AGENT is a medical device that received FDA 510(k) clearance on 2007-03-20. The listed applicant is Dmg USA, Inc.. The 510(k) number is K063444.

When did TOTAL ETCH BONDING AGENT receive FDA 510(k) clearance?

TOTAL ETCH BONDING AGENT received FDA 510(k) clearance on 2007-03-20, under 510(k) number K063444.

Who is the listed applicant for TOTAL ETCH BONDING AGENT?

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

What is the FDA product code for TOTAL ETCH BONDING AGENT?

The FDA product code for TOTAL ETCH BONDING AGENT 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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