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FDA 510(k)

TEMPBOND CLEAR-2

K-Number: K982590 · 1998-10-08

ApplicantSybron Dental Specialties, Inc.
Decision Date1998-10-08
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TEMPBOND CLEAR-2 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 1998-10-08 under 510(k) number K982590. 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 TEMPBOND CLEAR-2?

TEMPBOND CLEAR-2 is a medical device that received FDA 510(k) clearance on 1998-10-08. The listed applicant is Sybron Dental Specialties, Inc.. The 510(k) number is K982590.

When did TEMPBOND CLEAR-2 receive FDA 510(k) clearance?

TEMPBOND CLEAR-2 received FDA 510(k) clearance on 1998-10-08, under 510(k) number K982590.

Who is the listed applicant for TEMPBOND CLEAR-2?

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 TEMPBOND CLEAR-2?

The FDA product code for TEMPBOND CLEAR-2 is EMA.

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Related Devices (Code: 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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