REFLECTIONS - CERAMIC DENTAL BRACKET— 510(k) K922499

Substantially Equivalent

Cdb Corp.

FDA 510(k) clearance K922499 for REFLECTIONS - CERAMIC DENTAL BRACKET, Substantially Equivalent on 1992-07-30. Applicant: Cdb Corp.. Device class: 1.

Clearance details

Applicant: Cdb Corp.
Product code: Code EJF
Device class: Class 1
Regulation: 21 CFR 872.5410
Advisory panel: Dental
Date received: 1992-05-27
Decision date: 1992-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EJF

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 Cdb Corp.

K973776 — REFLECTIONS1997-11-21
K934881 — REFLECTIONS1994-02-01

Recalls naming K922499

K-number listed on FDA's recall record

Z-0876-2013 — Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxide. The indicated use of the Avex CX ceramic bracket is the mechanical movement of natural teeth in conjunction with other components designed to attach to the brackets.Class III·Terminated·Ultradent Products, Inc.·20130208

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K922499.

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