BIJOU Orthodontic Ceramic Bracket— 510(k) K152167

Name: FDA 510(k) clearance K152167
Creator: U.S. Food and Drug Administration
Published: 2016-05-27

Substantially Equivalent

World Bio Tech Co., Ltd.

FDA 510(k) clearance K152167 for BIJOU Orthodontic Ceramic Bracket, Substantially Equivalent on 2016-05-27. Applicant: World Bio Tech Co., Ltd.. Device class: 2.

Clearance details

Applicant: World Bio Tech Co., Ltd.
Product code: Code NJM
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2015-08-04
Decision date: 2016-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code NJM

view all

K232827 — LightForce Orthodontic System2023-09-14
K232011 — Cleo2023-07-07
K231635 — A-Line Advanced2023-06-06
K230225 — DynaFlex Clear Brackets & Buttons2023-06-05
K222847 — Ceramic Brackets Orthometric2023-05-04

More clearances from World Bio Tech Co., Ltd.

view all

K120471 — MACH BRACKETS BRIGHT BRACKETS2012-06-04

Data sourced from openFDA. This site is unofficial and independent of the FDA.