EKM
23 FDA 510(k) clearances · Product code
57 daysmedian time to decision
158 days90th percentile
23clearances measured
FDA profile
- Official device name
- Gutta-Percha
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.3850
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 2008: 2 · 2009: 5 · 2010: 8 · 2013: 7 · 2014: 67 · 2015: 8
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| EI DOWNPAK BARRIER SLEEVES (K073369) | Hu-Friedy Mfg. Co., Inc. | 2008-02-27 |
| DOWN PAK (K070246) | Endo Twinn B.V. | 2007-02-16 |
| TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE) (K051573) | Dr. Howard Martin, P.A. | 2006-06-26 |
| ENDO TWINN (K042870) | Endo Twinn B.V. | 2005-01-11 |
| FIBERFILL SGP (K023819) | Pentron Clinical Technologies | 2003-03-26 |
| ANTIBACTERIAL GUTTA PERCHA (K971641) | Dr. Howard Martin, P.A. | 1997-07-21 |
| THERMAPREP PLUS OVEN (K970134) | Tulsa Dental Products, Ltd. | 1997-03-21 |
| INJECT-R FILL (K931742) | Union Broach, Div. Moyco Industries, Inc. | 1993-05-27 |
| MICRODOSE RC-EZ (K924825) | Unicep | 1993-03-05 |
| TOUCH 'N HEAT MODEL 5002, MODIFICATION (K915243) | Analytic Technology | 1992-01-21 |
| THERMAPREP (K910224) | Tulsa Dental Products, Ltd. | 1991-03-29 |
| THERMAFIL ENDODONTIC OBTURATOR (K900986) | Tulsa Dental Products, Ltd. | 1990-11-13 |
| ENDO-PREP (K896663) | Pulpdent Corp. | 1990-02-14 |
| THERMAFIL ENDODONTIC OBTURATOR (K881139) | Tulsa Dental Products, Ltd. | 1988-04-07 |
| GUTTA PERCHA POINTS (K863638) | Endodent, Inc. | 1986-10-30 |
| GUTTA PERCHA (K863411) | Endodent, Inc. | 1986-10-30 |
| SET CANAL SEALER PASTE (K862129) | Endo Technic Corp. | 1986-07-22 |
| ULTRAFIL-LT (GUTTA PERCHA) (K850863) | The Hygenic Corp. | 1985-04-16 |
| HEATED GUTTA PERCHA DELIVERY SYSTEM (K832654) | Unitek Corp. | 1983-09-26 |
| GUTTA PERCHA POINTS (K830114) | North Pacific Dental, Inc. | 1983-03-01 |
| PAPER POINTS (K830115) | North Pacific Dental, Inc. | 1983-03-01 |
| TOUCH-N-HEAT MODEL 5001 (K823486) | Analytic Technology | 1983-01-18 |
| OBTURATION SYSTEM KIT (K820639) | U.S. Shizai Corp. | 1982-04-09 |
Track EKM automatically
Every clearance here is in the API, with alerts when new ones post.