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FDA 510(k)

OPTIGUARD

K-Number: K945539 · 1994-12-29

ApplicantSybron Dental Specialties, Inc.
Decision Date1994-12-29
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OPTIGUARD 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 1994-12-29 under 510(k) number K945539. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTIGUARD?

OPTIGUARD is a medical device that received FDA 510(k) clearance on 1994-12-29. The listed applicant is Sybron Dental Specialties, Inc.. The 510(k) number is K945539.

When did OPTIGUARD receive FDA 510(k) clearance?

OPTIGUARD received FDA 510(k) clearance on 1994-12-29, under 510(k) number K945539.

Who is the listed applicant for OPTIGUARD?

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 OPTIGUARD?

The FDA product code for OPTIGUARD is EBF.

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Other records listing Sybron Dental Specialties, Inc. as applicant

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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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