ELB — Scaler, Rotary Class II
FDA product code ELB covers "Scaler, Rotary", a Class II medical device regulated under 21 CFR 872.4840. Submissions are reviewed by the Dental panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ELB
- Device Class
- Class II
- Regulation Number
- 872.4840
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K170596 | genoss co | TN-Brush | September 11, 2017 |
| K121114 | tigran technologies | TIGRAN PERIBRUSH | September 17, 2012 |
| K111724 | straumann usa | STRAUMANN TIBRUSH | September 12, 2011 |
| K003640 | sybron dental specialties | MINIENDO III | February 22, 2001 |
| K831037 | taco dental | AIR BURBINE HANDPIECE-DENTAL SCALING | May 9, 1983 |
| K782007 | star dental mfg | ROTARY SCALER | January 3, 1979 |