FDA product code EHK: Cup, Prophylaxis
EHK is the FDA product code for cup, prophylaxis. It is a Class I device, regulated under 21 CFR 872.6290 and reviewed by the Dental panel. FDA has cleared 8 510(k) submissions under EHK, from 8 different applicants. The average 510(k) review took 40 days (median 44). FDA has posted 1 recall for EHK devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Cup, Prophylaxis |
| Device class | Class I |
| Regulation | 21 CFR 872.6290 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every EHK clearance
Top EHK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Rolence Enterprise Co. , Ltd. | 1 | 1995-09-29 |
| Preventive Technologies, Inc. | 1 | 1995-05-02 |
| Dentsply Intl. | 1 | 1990-04-10 |
| Mission White Dental, Inc. | 1 | 1986-11-19 |
| Teledyne Densco | 1 | 1981-01-08 |
3 more applicants have EHK clearances. See the full list in Caduvo.
Most recent EHK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K953628 | Rolence Enterprise Co. , Ltd. | PROPHY ANGLE | 1995-09-29 | 60 |
| K951016 | Preventive Technologies, Inc. | DISPOSABLE PROPHYLAXIS ANGLE | 1995-05-02 | 57 |
| K900507 | Dentsply Intl. | DISPOSABLE SCREW TYPE PROPHY BRUSH | 1990-04-10 | 67 |
| K864059 | Mission White Dental, Inc. | DENTAL PROPHY CUPS (VARIOUS TYPES) | 1986-11-19 | 30 |
| K803155 | Teledyne Densco | PROPHYLAXIS CUP. | 1981-01-08 | 27 |
Recalls for EHK devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-07-20.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code EHK?
EHK is the FDA product code for cup, prophylaxis. It is a Class I device, regulated under 21 CFR 872.6290 and reviewed by the Dental panel.
What device class is EHK?
Class I, regulation 21 CFR 872.6290. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EHK?
Across 8 cleared submissions the average was 40 days from receipt to decision (median 44).
Which companies have the most EHK clearances?
Rolence Enterprise Co. , Ltd. (1); Preventive Technologies, Inc. (1); Dentsply Intl. (1); Mission White Dental, Inc. (1); Teledyne Densco (1).
Have EHK devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2023-07-20.
Next steps
- Run an FDA pathway report with predicate devices for product code EHK
- Run a recall and safety report across every EHK manufacturer
- Watch product code EHK 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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