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FDA 510(k)

TEMPBOND CLEAR WITH TRICLOSAN

K-Number: K053565 · 2006-02-03

ApplicantSybron Dental Specialties, Inc.
Decision Date2006-02-03
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TEMPBOND CLEAR WITH TRICLOSAN 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 2006-02-03 under 510(k) number K053565. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEMPBOND CLEAR WITH TRICLOSAN?

TEMPBOND CLEAR WITH TRICLOSAN is a medical device that received FDA 510(k) clearance on 2006-02-03. The listed applicant is Sybron Dental Specialties, Inc.. The 510(k) number is K053565.

When did TEMPBOND CLEAR WITH TRICLOSAN receive FDA 510(k) clearance?

TEMPBOND CLEAR WITH TRICLOSAN received FDA 510(k) clearance on 2006-02-03, under 510(k) number K053565.

Who is the listed applicant for TEMPBOND CLEAR WITH TRICLOSAN?

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 TEMPBOND CLEAR WITH TRICLOSAN?

The FDA product code for TEMPBOND CLEAR WITH TRICLOSAN is EMA.

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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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