FDA 510(k) Premarket Notification K040797: BRITESMILE MASKING CREAM

Submission Details & Decision

Normalized public record details for 510(k) notification K040797.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K040797

Applicant / Sponsor

Britesmile, Inc.

Device Name

BRITESMILE MASKING CREAM

Product Code

EIE

Decision Date

2004-04-02

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Dental (DE)

Clearance Type

Special

Third Party Flag

Date Received

2004-03-29

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