FDA product code EHL: Point, Abrasive
EHL is the FDA product code for point, abrasive. It is a Class I device, regulated under 21 CFR 872.6010 and reviewed by the Dental panel. FDA has cleared 4 510(k) submissions under EHL, from 2 different applicants. The average 510(k) review took 31 days (median 20).
Classification
| Field | Value |
|---|---|
| Device name | Point, Abrasive |
| Device class | Class I |
| Regulation | 21 CFR 872.6010 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every EHL clearance
Top EHL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cavitron Corp. | 3 | 1978-06-22 |
| Cutter Laboratories, Inc. | 1 | 1980-01-23 |
Most recent EHL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K792250 | Cutter Laboratories, Inc. | CUTTER POINTS | 1980-01-23 | 76 |
| K780811 | Cavitron Corp. | DENTAL ABRASIVE DEVICE | 1978-06-22 | 35 |
| K780376 | Cavitron Corp. | MINIDENTOFLEX NEW POLISHING SYSTEM | 1978-03-14 | 6 |
| K780377 | Cavitron Corp. | PINIDENTOFLEX DENTAL POLISHER | 1978-03-14 | 6 |
Recalls for EHL devices
openFDA lists no recalls for product code EHL.
Frequently asked questions
What is FDA product code EHL?
EHL is the FDA product code for point, abrasive. It is a Class I device, regulated under 21 CFR 872.6010 and reviewed by the Dental panel.
What device class is EHL?
Class I, regulation 21 CFR 872.6010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EHL?
Across 4 cleared submissions the average was 31 days from receipt to decision (median 20).
Which companies have the most EHL clearances?
Cavitron Corp. (3); Cutter Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EHL
- Run a recall and safety report across every EHL manufacturer
- Watch product code EHL 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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