A-Line Advanced

Q: When was A-Line Advanced cleared by the FDA?

A-Line Advanced (K231635) received a 510(k) decision of Substantially Equivalent on June 6, 2023, 1 days after the submission was received.

Q: What is the product code of K231635?

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

FDA 510(k) K231635 · Biocetec Co., Ltd.

Substantially Equivalent

510(k) numberK231635

Submission

Device name: A-Line Advanced
Applicant: Biocetec Co., Ltd.
Seoul, KR
Received: June 5, 2023
Decision date: June 6, 2023
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA
Third-party review: Yes

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)	Device	Applicant	Decision
K232827	LightForce Orthodontic SystemNJM · Traditional	Lightforce Orthodontics	09/14/2023SE
K232011	CleoNJM · Traditional	American Orthodontics	07/07/2023SE
K230225	DynaFlex Clear Brackets & ButtonsNJM · Traditional	Dyna Flex	06/05/2023SE
K222847	Ceramic Brackets OrthometricNJM · Traditional	Orthometric - Industria E Comercio DE Produtos…	05/04/2023SE
K222764	LightForce Orthodontic SystemNJM · Special	Lightforce Orthodontics	09/14/2022SE
K220689	Vatech ClismileNJM · Traditional	Rayence Co., Ltd.	05/06/2022SE
K201410	VENUS Bracket, ROSE BracketNJM · Traditional	Gni Co., Ltd.	03/12/2021SE
K201038	Luce Ceramic BracketNJM · Traditional	Luce Castle Co., Ltd.	10/09/2020SE
K200148	LightForce Orthodontic System (LFO System)NJM · Traditional	Lightforce Orthodontics	02/21/2020SE
K182672	ROSA BracketNJM · Traditional	Gni Co., Ltd.	11/15/2019SE

More from Gni Co., Ltd.

510(k)	Device	Decision
K190871	Bio-TackS Orthodontic Mini ImplantOAT · Traditional	01/17/2020SE
K182193	S-LineNJM · Traditional	01/22/2019SE
K163467	C-Line Orthodontic Ceramic BracketNJM · Traditional	06/14/2017SE

Questions and answers

When was A-Line Advanced cleared by the FDA?

A-Line Advanced (K231635) received a 510(k) decision of Substantially Equivalent on June 6, 2023, 1 days after the submission was received.

What is the product code of K231635?

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