Ortho VLC; Ortho VLC Capsule

FDA 510(k) K011521 · First Scientific Limited

Substantially Equivalent

510(k) numberK011521

Submission

Device name
Ortho VLC; Ortho VLC Capsule
Applicant
First Scientific Limited
Blaenau Gwent, Wales, GB
Received
May 17, 2001
Decision date
August 1, 2001
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DYH – Adhesive, Bracket And Tooth Conditioner, Resin
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3750
Specialty
Dental

Other 510(k)s with product code DYH

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K250015Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree AdhesiveDYH · Traditional Ormco Corporation01/03/2025SE
K242537BracePaste Fluoride SealantDYH · Traditional American Orthodontics Corp.08/27/2024SE
K2340433M™ Transbond™ Orthodontic AdhesiveDYH · Traditional 3M Unitek Orthodontic Products12/22/2023SE
K231817AlignerFlow LCDYH · Traditional Voco GmbH12/01/2023SE
K214054TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP…DYH · Traditional Tp Orthodontics, Inc.10/14/2022SE
K210115FiteBac CC OrthoSealDYH · Traditional Largent Health, LLC07/29/2021SE
K202276BracePaste Band and Build LCDYH · Traditional American Orthodontics08/14/2020SE
K192682Orthocem, Ortho BiteDYH · Traditional Dentscare Ltda08/14/2020SE

More from Dentscare Ltda

510(k)DeviceDecision
K011520Restore-XEMA · Traditional 07/23/2001SE
K011517Lute; CoreEBF · Traditional 07/10/2001SE
K011295Restore-Pf Vic; Restore-Pf VLC CapsuleEBF · Traditional 06/27/2001SE
K011309Lute VLC; Core VLCEBF · Traditional 06/22/2001SE

Questions and answers

When was Ortho VLC; Ortho VLC Capsule cleared by the FDA?

Ortho VLC; Ortho VLC Capsule (K011521) received a 510(k) decision of Substantially Equivalent on August 1, 2001, 76 days after the submission was received.

What is the product code of K011521?

The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.