Vivid Aligners

Aligner, Sequential

Orthodent Laboratory, Inc.

The following data is part of a premarket notification filed by Orthodent Laboratory, Inc. with the FDA for Vivid Aligners.

Pre-market Notification Details

Device IDK190003
510k NumberK190003
Device Name:Vivid Aligners
ClassificationAligner, Sequential
Applicant Orthodent Laboratory, Inc. 6325 Sheridan Drive Buffalo,  NY  14221
ContactMichael Wright
CorrespondentRobert O. Dean
Compliance Systems International, LLC. 1083 Delaware Ave. Buffalo,  NY  14209
Product CodeNXC  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-01-02
Decision Date2019-11-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860011027201 K190003 000

Trademark Results [Vivid Aligners]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VIVID ALIGNERS
VIVID ALIGNERS
86964420 5085985 Live/Registered
Orthodent Lab
2016-04-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.