ELB
6 FDA 510(k) clearances · Product code
87 daysmedian time to decision
195 days90th percentile
6clearances measured
FDA profile
- Official device name
- Scaler, Rotary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.4840
- Medical specialty
- Dental
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1999: 1 · 2002: 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 |
|---|---|---|
| TN-Brush (K170596) | Genoss Co., Ltd. | 2017-09-11 |
| TIGRAN PERIBRUSH (K121114) | Tigran Technologies AB | 2012-09-17 |
| STRAUMANN TIBRUSH (K111724) | Straumann USA | 2011-09-12 |
| MINIENDO III (K003640) | Sybron Dental Specialties, Inc. | 2001-02-22 |
| AIR BURBINE HANDPIECE-DENTAL SCALING (K831037) | Taco Dental, Inc. | 1983-05-09 |
| ROTARY SCALER (K782007) | Star Dental Mfg. Co. | 1979-01-03 |
Track ELB automatically
Every clearance here is in the API, with alerts when new ones post.