ORTHODONTIC METAL BRACKET— 510(k) K923261

Name: FDA 510(k) clearance K923261
Creator: U.S. Food and Drug Administration
Published: 1992-12-03

Substantially Equivalent

American Orthodontics

FDA 510(k) clearance K923261 for ORTHODONTIC METAL BRACKET, Substantially Equivalent on 1992-12-03. Applicant: American Orthodontics. Device class: 1.

Clearance details

Applicant: American Orthodontics
Product code: Code EJF
Device class: Class 1
Regulation: 21 CFR 872.5410
Advisory panel: Dental
Date received: 1992-07-02
Decision date: 1992-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sheboygan, WI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EJF

view all

K994357 — BITEM LOCK, MODELS SW006, SW0122000-03-14
K932825 — MICROARCH GOLD BRACKET1994-05-09
K933501 — ALASTIK1994-04-28
K923372 — MEMORY WIRE1994-04-22
K933080 — ORTHOTECH DURA-GOLD BARCKETS1994-03-23

More clearances from American Orthodontics

view all

K261840 — BracePaste Prime Plus2026-06-03
K232011 — Cleo2023-07-07
K202276 — BracePaste Band and Build LC2020-08-14
K181910 — BracePaste MTP Light Cure Primer2018-10-15
K172953 — Acid Etchant2018-02-06

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