FDA product code EHJ: Disk, Abrasive
EHJ is the FDA product code for disk, 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 EHJ, from 4 different applicants. The average 510(k) review took 79 days (median 22). FDA has posted 2 recalls for EHJ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Disk, 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 EHJ clearance
Top EHJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Vermont Diamond Instruments | 1 | 1991-11-19 |
| Centrix, Inc. | 1 | 1987-08-17 |
| E.C. Moore Co. | 1 | 1979-05-01 |
| Cavitron Corp. | 1 | 1977-09-12 |
Most recent EHJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K911111 | Vermont Diamond Instruments | MICROMILLS, PATRIOTS, ALPHA GOLD DIAMONDS | 1991-11-19 | 257 |
| K873002 | Centrix, Inc. | MIN-IDENTOFLEX | 1987-08-17 | 13 |
| K790640 | E.C. Moore Co. | HOWMEDICA BRASS CENTER DISC | 1979-05-01 | 32 |
| K771658 | Cavitron Corp. | IDENTOFLEX | 1977-09-12 | 13 |
Recalls for EHJ devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-01-28.
| Year | Recalls |
|---|---|
| 2026 | 1 |
Frequently asked questions
What is FDA product code EHJ?
EHJ is the FDA product code for disk, abrasive. It is a Class I device, regulated under 21 CFR 872.6010 and reviewed by the Dental panel.
What device class is EHJ?
Class I, regulation 21 CFR 872.6010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EHJ?
Across 4 cleared submissions the average was 79 days from receipt to decision (median 22).
Which companies have the most EHJ clearances?
Vermont Diamond Instruments (1); Centrix, Inc. (1); E.C. Moore Co. (1); Cavitron Corp. (1).
Have EHJ devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2026-01-28.
Next steps
- Run an FDA pathway report with predicate devices for product code EHJ
- Run a recall and safety report across every EHJ manufacturer
- Watch product code EHJ 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.
All Dental product codes · FDA product code lookup · 510(k) database search · 510(k) review times