FDA Product Code
FDA Product Code EKM — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3850
510(k) Clearances — 23 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K073369 | EI DOWNPAK BARRIER SLEEVES | Hu-Friedy Mfg. Co., Inc. | 2008-02-27 | Traditional | PDF ↗ |
| K070246 | DOWN PAK | Endo Twinn B.V. | 2007-02-16 | Special | PDF ↗ |
| K051573 | TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE) | Dr. Howard Martin, P.A. | 2006-06-26 | Traditional | PDF ↗ |
| K042870 | ENDO TWINN | Endo Twinn B.V. | 2005-01-11 | Traditional | PDF ↗ |
| K023819 | FIBERFILL SGP | Pentron Clinical Technologies | 2003-03-26 | Traditional | PDF ↗ |
| K971641 | ANTIBACTERIAL GUTTA PERCHA | Dr. Howard Martin, P.A. | 1997-07-21 | Traditional | PDF ↗ |
| K970134 | THERMAPREP PLUS OVEN | Tulsa Dental Products, Ltd. | 1997-03-21 | Traditional | PDF ↗ |
| K931742 | INJECT-R FILL | Union Broach, Div. Moyco Industries, Inc. | 1993-05-27 | Traditional | PDF ↗ |
| K924825 | MICRODOSE RC-EZ | Unicep | 1993-03-05 | Traditional | PDF ↗ |
| K915243 | TOUCH 'N HEAT MODEL 5002, MODIFICATION | Analytic Technology | 1992-01-21 | Traditional | PDF ↗ |
| K910224 | THERMAPREP | Tulsa Dental Products, Ltd. | 1991-03-29 | Traditional | PDF ↗ |
| K900986 | THERMAFIL ENDODONTIC OBTURATOR | Tulsa Dental Products, Ltd. | 1990-11-13 | Traditional | PDF ↗ |
| K896663 | ENDO-PREP | Pulpdent Corp. | 1990-02-14 | Traditional | PDF ↗ |
| K881139 | THERMAFIL ENDODONTIC OBTURATOR | Tulsa Dental Products, Ltd. | 1988-04-07 | Traditional | PDF ↗ |
| K863411 | GUTTA PERCHA | Endodent, Inc. | 1986-10-30 | Traditional | PDF ↗ |
| K863638 | GUTTA PERCHA POINTS | Endodent, Inc. | 1986-10-30 | Traditional | PDF ↗ |
| K862129 | SET CANAL SEALER PASTE | Endo Technic Corp. | 1986-07-22 | Traditional | PDF ↗ |
| K850863 | ULTRAFIL-LT (GUTTA PERCHA) | The Hygenic Corp. | 1985-04-16 | Traditional | PDF ↗ |
| K832654 | HEATED GUTTA PERCHA DELIVERY SYSTEM | Unitek Corp. | 1983-09-26 | Traditional | PDF ↗ |
| K830115 | PAPER POINTS | North Pacific Dental, Inc. | 1983-03-01 | Traditional | PDF ↗ |
| K830114 | GUTTA PERCHA POINTS | North Pacific Dental, Inc. | 1983-03-01 | Traditional | PDF ↗ |
| K823486 | TOUCH-N-HEAT MODEL 5001 | Analytic Technology | 1983-01-18 | Traditional | PDF ↗ |
| K820639 | OBTURATION SYSTEM KIT | U.S. Shizai Corp. | 1982-04-09 | Traditional | PDF ↗ |
Product code EKM · Class I · Dental. Data: openFDA.