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FDA 510(k)

SOUTH BEACH SMILE LIGHT WHITENING SYSTEM

K-Number: K042153 · 2004-11-08

ApplicantDentovations, Inc.
Decision Date2004-11-08
Product CodeEEG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SOUTH BEACH SMILE LIGHT WHITENING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dentovations, Inc.. It received FDA 510(k) clearance on 2004-11-08 under 510(k) number K042153. The device is classified under product code EEG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOUTH BEACH SMILE LIGHT WHITENING SYSTEM?

SOUTH BEACH SMILE LIGHT WHITENING SYSTEM is a medical device that received FDA 510(k) clearance on 2004-11-08. The listed applicant is Dentovations, Inc.. The 510(k) number is K042153.

When did SOUTH BEACH SMILE LIGHT WHITENING SYSTEM receive FDA 510(k) clearance?

SOUTH BEACH SMILE LIGHT WHITENING SYSTEM received FDA 510(k) clearance on 2004-11-08, under 510(k) number K042153.

Who is the listed applicant for SOUTH BEACH SMILE LIGHT WHITENING SYSTEM?

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

What is the FDA product code for SOUTH BEACH SMILE LIGHT WHITENING SYSTEM?

The FDA product code for SOUTH BEACH SMILE LIGHT WHITENING SYSTEM is EEG.

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Related Devices (Code: EEG)

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.

K122725TANDA PEARL, ULTRAWYTE, PEARLSyneron BeautyK110888ABSOLUTE WHITE LIGHTDr. Fresh, Inc.K063704BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101Beks IncorporatedK052040QUICKSMILECosmetic Dental Materials, Inc.K041392SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC, MODEL QUICK WHITE USCAO Group, Inc.K895174UNION BROACH BLEACHING LIGHTUnion Broach, Div. Moyco Industries, Inc.

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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