EKP
6 FDA 510(k) clearances · Product code
21 daysmedian time to decision
62 days90th percentile
6clearances measured
FDA profile
- Official device name
- Reamer, Pulp Canal, Endodontic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.4565
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 2004: 1 · 2005: 2
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 |
|---|---|---|
| REAMER TYPE K ENDODONTIC (K823686) | United Dental Mfg., Inc. | 1982-12-28 |
| ROOT CANAL REAMERS, TYPE K (K822620) | Union Broach, Div. Moyco Industries, Inc. | 1982-09-28 |
| ENDEX REAMERS PULP CANAL, ENDODONTIC (K800291) | Ipco Corp. | 1980-02-19 |
| DIALYSIS, JET SYSTEM (K770331) | Janneck Ent. of Texas | 1977-04-20 |
| ENDODONTIC INSTRUMENTS, R&R CUTWELL (K770598) | Ransom and Randolph | 1977-04-05 |
| ROOT CANAL FILES & REAMERS (K770367) | Cemco Tool Co., Inc. | 1977-03-01 |
Track EKP automatically
Every clearance here is in the API, with alerts when new ones post.