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FDA 510(k)

EXTRUDE MODIFIED

K-Number: K012405 · 2001-09-04

ApplicantSybron Dental Specialties, Inc.
Decision Date2001-09-04
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EXTRUDE MODIFIED 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 2001-09-04 under 510(k) number K012405. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTRUDE MODIFIED?

EXTRUDE MODIFIED is a medical device that received FDA 510(k) clearance on 2001-09-04. The listed applicant is Sybron Dental Specialties, Inc.. The 510(k) number is K012405.

When did EXTRUDE MODIFIED receive FDA 510(k) clearance?

EXTRUDE MODIFIED received FDA 510(k) clearance on 2001-09-04, under 510(k) number K012405.

Who is the listed applicant for EXTRUDE MODIFIED?

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 EXTRUDE MODIFIED?

The FDA product code for EXTRUDE MODIFIED is ELW.

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Related Devices (Code: ELW)

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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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