FDA Device Intelligence
HomeOrtho Organizers, Inc. › PURE®

PURE®

Ortho Organizers, Inc. · Model S22811 · UDI-DI 00190707107918

NJM Prescription
1
510(k) clearances
23
Adverse events
1
Recalls
47
Facilities

Description

PURE® McLaughlin .022 UR2 Rx +10° Tor. +8° Ang.(10PK)

Recalls

DateFirmReason
2013-11-19Ultradent 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 keyRead 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.