FDA product code EIK: Carver, Wax, Dental
EIK is the FDA product code for carver, wax, dental. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 5 510(k) submissions under EIK, from 5 different applicants. The average 510(k) review took 89 days (median 80).
Classification
| Field | Value |
|---|---|
| Device name | Carver, Wax, Dental |
| 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 EIK clearance
Top EIK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Stephen M Koral, Dmd | 1 | 2002-02-22 |
| Estrad B.V. | 1 | 1998-01-26 |
| Intl. Equipment and Supply Corp. | 1 | 1990-09-13 |
| Pacific Union Dental, Inc. | 1 | 1986-03-17 |
| Artiberia | 1 | 1985-07-02 |
Most recent EIK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K013993 | Stephen M Koral, Dmd | NEOCALEX | 2002-02-22 | 80 |
| K972642 | Estrad B.V. | PERIO CONTROL II | 1998-01-26 | 195 |
| K902653 | Intl. Equipment and Supply Corp. | PDS-2000 | 1990-09-13 | 90 |
| K860817 | Pacific Union Dental, Inc. | ROOT CANAL ORGANIZER | 1986-03-17 | 13 |
| K851727 | Artiberia | 2020-1/2 TO 2220 VARIOUS DENTAL WAX & MODELLING CA | 1985-07-02 | 68 |
Recalls for EIK devices
openFDA lists no recalls for product code EIK.
Frequently asked questions
What is FDA product code EIK?
EIK is the FDA product code for carver, wax, dental. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EIK?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EIK?
Across 5 cleared submissions the average was 89 days from receipt to decision (median 80).
Which companies have the most EIK clearances?
Stephen M Koral, Dmd (1); Estrad B.V. (1); Intl. Equipment and Supply Corp. (1); Pacific Union Dental, Inc. (1); Artiberia (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EIK
- Run a recall and safety report across every EIK manufacturer
- Watch product code EIK 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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