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EdgeSequel™
US ENDODONTICS, LLC · Model ESS2006PP · UDI-DI 00818365027552
EKN
Prescription
7
510(k) clearances
0
Adverse events
5
Recalls
86
Facilities
Description
EdgeSequel™ .06 Paper Points™ 20
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-08-04 | Ultradent Products, Inc. | The barcode label was placed underneath the sterile barrier and the product was re-wrapped. |
| 2017-08-04 | Ultradent Products, Inc. | The barcode label was placed underneath the sterile barrier and the product was re-wrapped. |
| 2017-08-04 | Ultradent Products, Inc. | The barcode label was placed underneath the sterile barrier and the product was re-wrapped. |
| 2017-08-04 | Ultradent Products, Inc. | The barcode label was placed underneath the sterile barrier and the product was re-wrapped. |
| 2017-08-04 | Ultradent Products, Inc. | The barcode label was placed underneath the sterile barrier and the product was re-wrapped. |
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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.