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FDA 510(k)

OPTIBOND ALL-IN-ONE

K-Number: K060469 · 2006-03-28

ApplicantSybron Dental Specialties, Inc.
Decision Date2006-03-28
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OPTIBOND ALL-IN-ONE 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 2006-03-28 under 510(k) number K060469. 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 OPTIBOND ALL-IN-ONE?

OPTIBOND ALL-IN-ONE is a medical device that received FDA 510(k) clearance on 2006-03-28. The listed applicant is Sybron Dental Specialties, Inc.. The 510(k) number is K060469.

When did OPTIBOND ALL-IN-ONE receive FDA 510(k) clearance?

OPTIBOND ALL-IN-ONE received FDA 510(k) clearance on 2006-03-28, under 510(k) number K060469.

Who is the listed applicant for OPTIBOND ALL-IN-ONE?

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 OPTIBOND ALL-IN-ONE?

The FDA product code for OPTIBOND ALL-IN-ONE is KLE.

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Related Devices (Code: KLE)

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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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