ERL
- Product code
- ERL
- Device name
- Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- Device class
- Class 2
- 21 CFR
- 21 CFR 874.4250
- Medical specialty
- Ear, Nose, Throat
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 91
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K243280 | 2025-07-03 | W&H Dentalwerk Buermoos GmbH | Piezomed Pro (Piezomed Pro module M-PM100 incl. hand | |
| K233958 | 2024-03-14 | Zethon, Ltd. | hekaDrill |
Official FDA classification page: ERL
Classification and pathway per current FDA publications. Data from openFDA (CC0).