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PURE
ORTHO TECHNOLOGY, INC. · Model S18021 · UDI-DI 00190730003218
NJM
Prescription
1
510(k) clearances
23
Adverse events
1
Recalls
47
Facilities
Description
PURE® Roth 018 UR3 Hk Rx +2º Tor. +8º Ang.(10PK)
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. |
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Get your free API keyRead the docsData 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.