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FDA 510(k)

FERMIT N PLUS

K-Number: K003377 · 2000-12-04

ApplicantIvoclar North America, Inc.
Decision Date2000-12-04
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FERMIT N PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar North America, Inc.. It received FDA 510(k) clearance on 2000-12-04 under 510(k) number K003377. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FERMIT N PLUS?

FERMIT N PLUS is a medical device that received FDA 510(k) clearance on 2000-12-04. The listed applicant is Ivoclar North America, Inc.. The 510(k) number is K003377.

When did FERMIT N PLUS receive FDA 510(k) clearance?

FERMIT N PLUS received FDA 510(k) clearance on 2000-12-04, under 510(k) number K003377.

Who is the listed applicant for FERMIT N PLUS?

The FDA 510(k) record lists Ivoclar North America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FERMIT N PLUS?

The FDA product code for FERMIT N PLUS is EBG.

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Other records listing Ivoclar North America, Inc. as applicant

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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Related Devices (Code: EBG)

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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