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FDA 510(k)

OPTIBOND SE

K-Number: K100347 · 2010-04-30

ApplicantKerr Corporation
Decision Date2010-04-30
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OPTIBOND SE is the device name listed in this FDA 510(k) record. The listed applicant is Kerr Corporation. It received FDA 510(k) clearance on 2010-04-30 under 510(k) number K100347. 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 SE?

OPTIBOND SE is a medical device that received FDA 510(k) clearance on 2010-04-30. The listed applicant is Kerr Corporation. The 510(k) number is K100347.

When did OPTIBOND SE receive FDA 510(k) clearance?

OPTIBOND SE received FDA 510(k) clearance on 2010-04-30, under 510(k) number K100347.

Who is the listed applicant for OPTIBOND SE?

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

What is the FDA product code for OPTIBOND SE?

The FDA product code for OPTIBOND SE is KLE.

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Other records listing Kerr Corporation 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.

K252890ZenSeal ProK222830Rainbow 360K221255SimpliShade Bulk Fill, SimpliShade Bulk Fill FlowK191548Nexus Universal Self-CureK182162OptiBond eXTRa UniversalK162948Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials

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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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