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FDA 510(k)

OPTIBOND SOLO PLUS ACTIVATOR

K-Number: K012082 · 2001-09-20

ApplicantSybron Dental Specialties, Inc.
Decision Date2001-09-20
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OPTIBOND SOLO PLUS ACTIVATOR 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 2001-09-20 under 510(k) number K012082. 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 SOLO PLUS ACTIVATOR?

OPTIBOND SOLO PLUS ACTIVATOR is a medical device that received FDA 510(k) clearance on 2001-09-20. The listed applicant is Sybron Dental Specialties, Inc.. The 510(k) number is K012082.

When did OPTIBOND SOLO PLUS ACTIVATOR receive FDA 510(k) clearance?

OPTIBOND SOLO PLUS ACTIVATOR received FDA 510(k) clearance on 2001-09-20, under 510(k) number K012082.

Who is the listed applicant for OPTIBOND SOLO PLUS ACTIVATOR?

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 SOLO PLUS ACTIVATOR?

The FDA product code for OPTIBOND SOLO PLUS ACTIVATOR is KLE.

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Other records listing Sybron Dental Specialties, Inc. as applicant

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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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