Gutta-Percha
Regulation 872.3850
0510(k)s in 12 months (23 all time)
0recalls in 12 months (3 all time)
1recalls that name a 510(k)
Top companies in EKM
| Company | 510(k)s | Recalls |
|---|---|---|
| Tulsa Dental Products, Ltd. | 4 | 0 |
| Analytic Technology | 2 | 0 |
| Dr. Howard Martin, P.A. | 2 | 0 |
| Endo Twinn B.V. | 2 | 0 |
| Endodent, Inc. | 2 | 0 |
| North Pacific Dental, Inc. | 2 | 0 |
| Endo Technic Corp. | 1 | 0 |
| Hu-Friedy Mfg. Co., Inc. | 1 | 0 |
| The Hygenic Corp. | 1 | 0 |
| Ormco Corporation | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 8, 2016 | Ormco/Sybronendo TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541
Intended to fill a endontontically obturated root canal treatment Terminated |
EKM | None listed |
| Nov 4, 2011 | Ormco Corporation Microseal Master Cone Part Number: 815-9033
Microseal Master Cone is intended to obturate root canals during endodontic therapy procedures. Terminated |
EKM | None listed |
| Dec 9, 2009 | Sybronendo Elements Gutta Percha and Elements RealSeal Cartridges; Part Number: 972-1002, 972-1003, 972-2001, 972-2002 Terminated |
EKM | K023819 |
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