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FDA 510(k)

MODIFICATION OF MILLENNIUM

K-Number: K990219 · 1999-02-24

ApplicantBiolase Technology, Inc.
Decision Date1999-02-24
Product CodeMXF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION OF 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 1999-02-24 under 510(k) number K990219. The device is classified under product code MXF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION OF MILLENNIUM?

MODIFICATION OF MILLENNIUM is a medical device that received FDA 510(k) clearance on 1999-02-24. The listed applicant is Biolase Technology, Inc.. The 510(k) number is K990219.

When did MODIFICATION OF MILLENNIUM receive FDA 510(k) clearance?

MODIFICATION OF MILLENNIUM received FDA 510(k) clearance on 1999-02-24, under 510(k) number K990219.

Who is the listed applicant for MODIFICATION OF 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 MODIFICATION OF MILLENNIUM?

The FDA product code for MODIFICATION OF MILLENNIUM is MXF.

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Other records listing Biolase Technology, 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.

K122368WATERLASE IPLUS ALL TISSUE LASERK130465EPIC 10SK121327DIOLASE 10SK121286EPIC 10K101658WATERLASE MD TURBO PLUS MODEL 7200XXXK093852EZLASE 3 LASER SYSTEM

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Related Devices (Code: MXF)

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.

K022803WATERLASE FOR APICOECTOMYBiolase Technology, Inc.K013908WATERLASE MILLENNIUMBiolase Technology, Inc.K012511WATERLASE MILLENNIUMBiolase Technology, Inc.K990908MILLENNIUMEndo Technic Corp.

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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