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FDA 510(k)

LAZERSMILE, LAZERWHITE

K-Number: K000290 · 2000-04-14

ApplicantBiolase Technology, Inc.
Decision Date2000-04-14
Product CodeEFW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LAZERSMILE, LAZERWHITE 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 2000-04-14 under 510(k) number K000290. The device is classified under product code EFW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAZERSMILE, LAZERWHITE?

LAZERSMILE, LAZERWHITE is a medical device that received FDA 510(k) clearance on 2000-04-14. The listed applicant is Biolase Technology, Inc.. The 510(k) number is K000290.

When did LAZERSMILE, LAZERWHITE receive FDA 510(k) clearance?

LAZERSMILE, LAZERWHITE received FDA 510(k) clearance on 2000-04-14, under 510(k) number K000290.

Who is the listed applicant for LAZERSMILE, LAZERWHITE?

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 LAZERSMILE, LAZERWHITE?

The FDA product code for LAZERSMILE, LAZERWHITE is EFW.

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Other records listing Biolase Technology, Inc. as applicant

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Related Devices (Code: EFW)

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.

K130186DENTEK EASY BRUSH WITH FLUORIDEDen Tek Oral Care, Inc.K121165BEAM BRUSH/BEAM APPBeam Technologies, LLCK102871SILVER CARE ANITBACTERIAL TOOTHBRUSHPiave Spazzolificio S.P.A.K073224ORAL-B SUB-BRAND MANUAL TOOTHBRUSHProcter & GambleK021383ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIALAgion Technologies, LLCK020776MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTSCoronet Group North America, LLC

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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