Home › Epien Medical, Inc. › HYBENX Root Canal Cleanser
HYBENX Root Canal Cleanser
Epien Medical, Inc. · Model 101-2002 · UDI-DI 00860004740308
KJJ
Prescription
10
510(k) clearances
24
Adverse events
7
Recalls
35
Facilities
Description
EPIEN Root Canal Cleanser is indicated for use as an adjunctive rinse of tooth root canal systems and adjacent tooth surfaces during standard professional dental procedures to enhance the removal of post-instrumentation dentinal debris and smear-layer within the root canal system.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-06-27 | Inter-Med Llc | The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and ex |
| 2019-06-27 | Inter-Med Llc | The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and ex |
| 2019-06-27 | Inter-Med Llc | The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and ex |
| 2019-06-27 | Inter-Med Llc | The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and ex |
| 2019-06-27 | Inter-Med Llc | The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and ex |
| 2019-06-27 | Inter-Med Llc | The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and ex |
| 2019-06-27 | Inter-Med Llc | The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and ex |
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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.