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FDA 510(k)

OPTIBOND 2A PRECOAT

K-Number: K955068 · 1995-12-11

ApplicantSybron Dental Specialties, Inc.
Decision Date1995-12-11
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OPTIBOND 2A PRECOAT 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 1995-12-11 under 510(k) number K955068. 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 OPTIBOND 2A PRECOAT?

OPTIBOND 2A PRECOAT is a medical device that received FDA 510(k) clearance on 1995-12-11. The listed applicant is Sybron Dental Specialties, Inc.. The 510(k) number is K955068.

When did OPTIBOND 2A PRECOAT receive FDA 510(k) clearance?

OPTIBOND 2A PRECOAT received FDA 510(k) clearance on 1995-12-11, under 510(k) number K955068.

Who is the listed applicant for OPTIBOND 2A PRECOAT?

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 2A PRECOAT?

The FDA product code for OPTIBOND 2A PRECOAT 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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