Home › Epien Medical, Inc. › HYBENX Advanced Dental Debridement Gel
HYBENX Advanced Dental Debridement Gel
Epien Medical, Inc. · Model 109-0004 · UDI-DI 00860004740322
KJJ
Prescription
10
510(k) clearances
24
Adverse events
7
Recalls
35
Facilities
Description
HYBENX Advanced Dental Debridement is a topical liquid or gel intended for use as an adjunctive decontamination rinse of tooth surfaces during the performance of certain dental procedures to help remove the smear layer and tooth debris.
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.