ELA — Instrument, Hand, Calculus Removal Class I
FDA product code ELA covers "Instrument, Hand, Calculus Removal", a Class I medical device regulated under 21 CFR 872.4565. Submissions are reviewed by the Dental panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ELA
- Device Class
- Class I
- Regulation Number
- 872.4565
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K952363 | ela medical | OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034) | August 15, 1995 |
| K854168 | travenol laboratories | TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES | March 13, 1986 |
| K823326 | miltex | DENTAL INSTRUMENTS - CUTTING INSTRUMENT | November 24, 1982 |
| K801974 | analytic technology | ANALYTIC TECH. METAL POINT HEATER #3001 | November 12, 1980 |