FDA product code ELA: Instrument, Hand, Calculus Removal
ELA is the FDA product code for instrument, hand, calculus removal. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 4 510(k) submissions under ELA, from 4 different applicants. The average 510(k) review took 89 days (median 96).
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Hand, Calculus Removal |
| Device class | Class I |
| Regulation | 21 CFR 872.4565 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every ELA clearance
Top ELA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ela Medical, Inc. | 1 | 1995-08-15 |
| Travenol Laboratories, S.A. | 1 | 1986-03-13 |
| Miltex, Inc. | 1 | 1982-11-24 |
| Analytic Technology | 1 | 1980-11-12 |
Most recent ELA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K952363 | Ela Medical, Inc. | OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034) | 1995-08-15 | 106 |
| K854168 | Travenol Laboratories, S.A. | TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES | 1986-03-13 | 149 |
| K823326 | Miltex, Inc. | DENTAL INSTRUMENTS - CUTTING INSTRUMENT | 1982-11-24 | 16 |
| K801974 | Analytic Technology | ANALYTIC TECH. METAL POINT HEATER #3001 | 1980-11-12 | 85 |
Recalls for ELA devices
openFDA lists no recalls for product code ELA.
Frequently asked questions
What is FDA product code ELA?
ELA is the FDA product code for instrument, hand, calculus removal. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is ELA?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ELA?
Across 4 cleared submissions the average was 89 days from receipt to decision (median 96).
Which companies have the most ELA clearances?
Ela Medical, Inc. (1); Travenol Laboratories, S.A. (1); Miltex, Inc. (1); Analytic Technology (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ELA
- Run a recall and safety report across every ELA manufacturer
- Watch product code ELA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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