FDA product code EHP: Clasp, Preformed
EHP is the FDA product code for clasp, preformed. It is a Class I device, regulated under 21 CFR 872.3285 and reviewed by the Dental panel. FDA has cleared 8 510(k) submissions under EHP, from 7 different applicants. The average 510(k) review took 80 days (median 67).
Classification
| Field | Value |
|---|---|
| Device name | Clasp, Preformed |
| Device class | Class I |
| Regulation | 21 CFR 872.3285 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EHP clearance
Top EHP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Vacudent Sales Corp. | 2 | 1980-05-20 |
| Inovativ, LLC | 1 | 2002-08-29 |
| Dentamax, Inc. | 1 | 1999-01-07 |
| Micro Dental Laboratories | 1 | 1998-02-10 |
| Pressing DI Monticelli Rag. Stefano | 1 | 1995-12-11 |
2 more applicants have EHP clearances. See the full list in Caduvo.
Most recent EHP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K022032 | Inovativ, LLC | ACETAL | 2002-08-29 | 69 |
| K983558 | Dentamax, Inc. | ACETAL DENTAL/PREFORMED CLASP | 1999-01-07 | 86 |
| K974622 | Micro Dental Laboratories | DENTAL D | 1998-02-10 | 61 |
| K955946 | Pressing DI Monticelli Rag. Stefano | ACETAL DENTAL/PREFORMED CLASP | 1995-12-11 | 45 |
| K954971 | B & H Technical Services , Ltd. | ACETAL DENTAL/PREFORMED CLASP | 1995-12-11 | 45 |
Recalls for EHP devices
openFDA lists no recalls for product code EHP.
Frequently asked questions
What is FDA product code EHP?
EHP is the FDA product code for clasp, preformed. It is a Class I device, regulated under 21 CFR 872.3285 and reviewed by the Dental panel.
What device class is EHP?
Class I, regulation 21 CFR 872.3285. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EHP?
Across 8 cleared submissions the average was 80 days from receipt to decision (median 67).
Which companies have the most EHP clearances?
Vacudent Sales Corp. (2); Inovativ, LLC (1); Dentamax, Inc. (1); Micro Dental Laboratories (1); Pressing DI Monticelli Rag. Stefano (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EHP
- Run a recall and safety report across every EHP manufacturer
- Watch product code EHP 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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