ELA
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Instrument, Hand, Calculus Removal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.4565
- Medical specialty
- Dental
Download CSV table Client report (share link) ◉ Watch
Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.
Building a predicate table? Click + Add on candidates below (up to 8), then compare and export from your Builder.
| Record | Firm | Date | Builder |
|---|---|---|---|
| OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034) (K952363) | Ela Medical, Inc. | 1995-08-15 | + Add |
| TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES (K854168) | Travenol Laboratories, S.A. | 1986-03-13 | + Add |
| DENTAL INSTRUMENTS - CUTTING INSTRUMENT (K823326) | Miltex, Inc. | 1982-11-24 | + Add |
| ANALYTIC TECH. METAL POINT HEATER #3001 (K801974) | Analytic Technology | 1980-11-12 | + Add |
Track ELA automatically
Every clearance here is in the API, with alerts when new ones post.