Home › G & H Wire Company, Inc. › CLARION™ ROTH METAL-LINED CERAMIC BRACKETS (KIT)

CLARION™ ROTH METAL-LINED CERAMIC BRACKETS (KIT)

G & H Wire Company, Inc. · Model 50K-345-18-01 · UDI-DI 10190886003602

NJM Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

CLARION™ ROTH .018 HK/345 METAL-LINED CERAMIC KIT W/CASE Clarion™ ceramic brackets feature a nickel-free silver alloy-lined archwire slot, making them a safe alternative for nickel sensitive patients. The metal slot is precisely integrated into the bracket body, creating a pleasantly aesthetic device that delivers the sliding mechanics of a metal slot. The Clarion™ ceramic bracket system also features a state-of-the art dovetail base design for maximum bonding surface between the bracket and adhesive. Successful bonding and debonding can be achieved using currently available bonding techniques.

Recalls

Date	Firm	Reason
2013-11-19	Ultradent Products, Inc.	Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.