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FDA 510(k)

TEMP-BOND NE 2

K-Number: K003658 · 2001-01-04

ApplicantSybron Dental Specialties, Inc.
Decision Date2001-01-04
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TEMP-BOND NE 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 2001-01-04 under 510(k) number K003658. 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 TEMP-BOND NE 2?

TEMP-BOND NE 2 is a medical device that received FDA 510(k) clearance on 2001-01-04. The listed applicant is Sybron Dental Specialties, Inc.. The 510(k) number is K003658.

When did TEMP-BOND NE 2 receive FDA 510(k) clearance?

TEMP-BOND NE 2 received FDA 510(k) clearance on 2001-01-04, under 510(k) number K003658.

Who is the listed applicant for TEMP-BOND NE 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 TEMP-BOND NE 2?

The FDA product code for TEMP-BOND NE 2 is EMA.

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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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