Ceramin Brackets Z

Q: When was Ceramin Brackets Z cleared by the FDA?

Ceramin Brackets Z (K123092) received a 510(k) decision of Substantially Equivalent on December 21, 2012, 80 days after the submission was received.

Q: What is the product code of K123092?

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

FDA 510(k) K123092 · Tomy, Inc.

Substantially Equivalent

510(k) numberK123092

Submission

Device name: Ceramin Brackets Z
Applicant: Tomy, Inc.
Bradenton, FL, US
Received: October 2, 2012
Decision date: December 21, 2012
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

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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

More from Lightforce Orthodontics

510(k)	Device	Decision
K180718	Orthodontic Plastic Brackets and AccessoriesDYW · Traditional	10/30/2018SE
K160615	Orthodontic Ceramic Brackets 1.1NJM · Traditional	08/26/2016SE
K123094	Orthodontic Ceramic BracketsNJM · Traditional	12/13/2012SE

Questions and answers

When was Ceramin Brackets Z cleared by the FDA?

Ceramin Brackets Z (K123092) received a 510(k) decision of Substantially Equivalent on December 21, 2012, 80 days after the submission was received.

What is the product code of K123092?

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