FDA product code EIS: Remover, Crown
EIS is the FDA product code for remover, crown. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 19 510(k) submissions under EIS, from 7 different applicants. The average 510(k) review took 81 days (median 84).
Classification
| Field | Value |
|---|---|
| Device name | Remover, Crown |
| 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 EIS clearance
Top EIS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Genesis Industries, Inc. | 13 | 1984-01-03 |
| J. Morita USA, Inc. | 1 | 1999-10-29 |
| Dentco, Inc. | 1 | 1995-08-29 |
| Pacific Union Dental, Inc. | 1 | 1986-09-22 |
| Fran Hazelton Co. | 1 | 1986-03-04 |
2 more applicants have EIS clearances. See the full list in Caduvo.
Most recent EIS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K992649 | J. Morita USA, Inc. | ATD AUTOMATIC BRIDGE REMOVER | 1999-10-29 | 84 |
| K951299 | Dentco, Inc. | EASY PNEUMATIC CROWN AND BRIDGE REMOVER | 1995-08-29 | 160 |
| K863500 | Pacific Union Dental, Inc. | STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR | 1986-09-22 | 13 |
| K854795 | Fran Hazelton Co. | HAZELTON TEMPORARY CROWN AND BRIDGE REMOVER | 1986-03-04 | 92 |
| K842026 | Higa Manufacturing , Ltd. | H-TYPE BRIDGE REMOVER | 1984-07-11 | 54 |
Recalls for EIS devices
openFDA lists no recalls for product code EIS.
Frequently asked questions
What is FDA product code EIS?
EIS is the FDA product code for remover, crown. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EIS?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EIS?
Across 19 cleared submissions the average was 81 days from receipt to decision (median 84).
Which companies have the most EIS clearances?
Genesis Industries, Inc. (13); J. Morita USA, Inc. (1); Dentco, Inc. (1); Pacific Union Dental, Inc. (1); Fran Hazelton Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EIS
- Run a recall and safety report across every EIS manufacturer
- Watch product code EIS 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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