EKR
6 FDA 510(k) clearances · Product code
63 daysmedian time to decision
335 days90th percentile
6clearances measured
FDA profile
- Official device name
- Plugger, Root Canal, Endodontic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.4565
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 2018: 45
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 |
|---|---|---|
| B&L L-BETA, MODEL WL-B1 (K060347) | B&L Biotech Co., Ltd. | 2006-06-05 |
| OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700 (K042828) | Young O/S, LLC | 2004-12-01 |
| ELEMENTS OBTURATION UNIT (K031664) | Sybron Endo/Analytic | 2004-04-28 |
| ENDODONTIC ROOT CANAL PLUGGER (K860569) | Dentsply Intl. | 1986-03-26 |
| ENDODONTIC ROOT CANAL PLUGGER FINGER- (K831748) | Union Branch | 1983-07-12 |
| MCSPADDEN CONDENSOR (K791019) | Techdent, Inc. | 1979-08-03 |
Track EKR automatically
Every clearance here is in the API, with alerts when new ones post.