EBL
11 FDA 510(k) clearances · Product code
41 daysmedian time to decision
174 days90th percentile
11clearances measured
FDA profile
- Official device name
- Pin, Retentive And Splinting, And Accessory Instruments
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.3740
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 1994: 2 · 1998: 1
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 |
|---|---|---|
| CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS) (K002693) | Cbs Intl. B.V. | 2000-11-09 |
| DENTAURUM JACKET CROWN & ROOT POSTS (K952868) | Dentauraum, Inc. | 1995-07-19 |
| ROOT CANAL POST (K924376) | The Thera Group | 1993-11-22 |
| PROSTHETIC RESTORATION DEVICE (K895283) | Swiss Precision Mfg. Corp. | 1990-02-14 |
| PLASTIC TOOTH REINFORCEMENT KIT (K895758) | Nanzee Dental Products | 1989-12-20 |
| ELGILOY (K883074) | Dale T. Dupuis | 1988-08-09 |
| VIVADENT FILPIN (K863831) | Vivadent (Usa), Inc. | 1986-10-14 |
| SECURIPIN (K844457) | Hughes Int'L, Inc. | 1984-12-27 |
| MARKLEY THREADED WIRE (K830773) | Almore Intl., Inc. | 1983-04-28 |
| REINFORCING PIN (K822412) | Filhol | 1982-08-30 |
| SAFE-T-PINS RETENTIVE PIN SYSTEM (K760723) | Parkell, Inc. | 1976-10-21 |
Track EBL automatically
Every clearance here is in the API, with alerts when new ones post.