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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 27, 2008 | K073369 | EI DOWNPAK BARRIER SLEEVES Hu-Friedy Mfg. Co., Inc. | EKM |
| Feb 16, 2007 | K070246 | DOWN PAK Endo Twinn B.V., NL | EKM |
| Jun 26, 2006 | K051573 | TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE) Dr. Howard Martin, P.A. | EKM |
| Jan 11, 2005 | K042870 | ENDO TWINN Endo Twinn B.V., NL | EKM |
| Mar 26, 2003 | K023819 | FIBERFILL SGP Pentron Clinical Technologies | EKM |
| Jul 21, 1997 | K971641 | ANTIBACTERIAL GUTTA PERCHA Dr. Howard Martin, P.A. | EKM |
| Mar 21, 1997 | K970134 | THERMAPREP PLUS OVEN Tulsa Dental Products, Ltd. | EKM |
| May 27, 1993 | K931742 | INJECT-R FILL Union Broach, Div. Moyco Industries, Inc. | EKM |
| Mar 5, 1993 | K924825 | MICRODOSE RC-EZ Unicep | EKM |
| Jan 21, 1992 | K915243 | TOUCH 'N HEAT MODEL 5002, MODIFICATION Analytic Technology | EKM |
| Mar 29, 1991 | K910224 | THERMAPREP Tulsa Dental Products, Ltd. | EKM |
| Nov 13, 1990 | K900986 | THERMAFIL ENDODONTIC OBTURATOR Tulsa Dental Products, Ltd. | EKM |
| Feb 14, 1990 | K896663 | ENDO-PREP Pulpdent Corp. | EKM |
| Apr 7, 1988 | K881139 | THERMAFIL ENDODONTIC OBTURATOR Tulsa Dental Products, Ltd. | EKM |
| Oct 30, 1986 | K863638 | GUTTA PERCHA POINTS Endodent, Inc. | EKM |
| Oct 30, 1986 | K863411 | GUTTA PERCHA Endodent, Inc. | EKM |
| Jul 22, 1986 | K862129 | SET CANAL SEALER PASTE Endo Technic Corp. | EKM |
| Apr 16, 1985 | K850863 | ULTRAFIL-LT (GUTTA PERCHA) The Hygenic Corp. | EKM |
| Sep 26, 1983 | K832654 | HEATED GUTTA PERCHA DELIVERY SYSTEM Unitek Corp. | EKM |
| Mar 1, 1983 | K830115 | PAPER POINTS North Pacific Dental, Inc. | EKM |
| Mar 1, 1983 | K830114 | GUTTA PERCHA POINTS North Pacific Dental, Inc. | EKM |
| Jan 18, 1983 | K823486 | TOUCH-N-HEAT MODEL 5001 Analytic Technology | EKM |
| Apr 9, 1982 | K820639 | OBTURATION SYSTEM KIT U.S. Shizai Corp. | EKM |
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