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FDA 510(k)

MILLENNIUM

K-Number: K980585 · 1998-10-08

ApplicantBiolase Technology, Inc.
Decision Date1998-10-08
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MILLENNIUM is the device name listed in this FDA 510(k) record. The listed applicant is Biolase Technology, Inc.. It received FDA 510(k) clearance on 1998-10-08 under 510(k) number K980585. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MILLENNIUM?

MILLENNIUM is a medical device that received FDA 510(k) clearance on 1998-10-08. The listed applicant is Biolase Technology, Inc.. The 510(k) number is K980585.

When did MILLENNIUM receive FDA 510(k) clearance?

MILLENNIUM received FDA 510(k) clearance on 1998-10-08, under 510(k) number K980585.

Who is the listed applicant for MILLENNIUM?

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

What is the FDA product code for MILLENNIUM?

The FDA product code for MILLENNIUM is EFB.

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Other records listing Biolase Technology, Inc. as applicant

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Related Devices (Code: EFB)

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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