S-Line

FDA 510(k) K182193 · Biocetec Co., Ltd.

Substantially Equivalent

510(k) numberK182193

Submission

Device name
S-Line
Applicant
Biocetec Co., Ltd.
Seoul, KR
Received
August 14, 2018
Decision date
January 22, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NJM – Bracket, Ceramic, Orthodontic
Device class
Class II (moderate risk)
Regulation
21 CFR 872.5470
Specialty
Dental

An orthodontic ceramic bracket is a device composed of ceramic, which is intended to be bonded to a tooth, upon which an orthodontic wire is used to move the tooth to a new position.

Other 510(k)s with product code NJM

510(k)DeviceApplicantDecision
K232827LightForce Orthodontic SystemNJM · Traditional Lightforce Orthodontics09/14/2023SE
K232011CleoNJM · Traditional American Orthodontics07/07/2023SE
K231635A-Line AdvancedNJM · Traditional Biocetec Co., Ltd.06/06/2023SE
K230225DynaFlex Clear Brackets & ButtonsNJM · Traditional Dyna Flex06/05/2023SE
K222847Ceramic Brackets OrthometricNJM · Traditional Orthometric - Industria E Comercio DE Produtos…05/04/2023SE
K222764LightForce Orthodontic SystemNJM · Special Lightforce Orthodontics09/14/2022SE
K220689Vatech ClismileNJM · Traditional Rayence Co., Ltd.05/06/2022SE
K201410VENUS Bracket, ROSE BracketNJM · Traditional Gni Co., Ltd.03/12/2021SE
K201038Luce Ceramic BracketNJM · Traditional Luce Castle Co., Ltd.10/09/2020SE
K200148LightForce Orthodontic System (LFO System)NJM · Traditional Lightforce Orthodontics02/21/2020SE

More from Lightforce Orthodontics

510(k)DeviceDecision
K231635A-Line AdvancedNJM · Traditional 06/06/2023SE
K190871Bio-TackS Orthodontic Mini ImplantOAT · Traditional 01/17/2020SE
K163467C-Line Orthodontic Ceramic BracketNJM · Traditional 06/14/2017SE

Questions and answers

When was S-Line cleared by the FDA?

S-Line (K182193) received a 510(k) decision of Substantially Equivalent on January 22, 2019, 161 days after the submission was received.

What is the product code of K182193?

The FDA product code is NJM – Bracket, Ceramic, Orthodontic, a Class II (moderate risk) device regulated under 21 CFR 872.5470.