FDA product code EIF: Accessories, Retractor, Dental
EIF is the FDA product code for accessories, retractor, dental. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 4 510(k) submissions under EIF, from 4 different applicants. The average 510(k) review took 93 days (median 54).
Classification
| Field | Value |
|---|---|
| Device name | Accessories, Retractor, 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 EIF clearance
Top EIF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Worldwide Dental, Inc. | 1 | 1994-10-05 |
| Cheri Lewis, D.D.S. | 1 | 1987-12-04 |
| Hematology Marketing Assoc. | 1 | 1983-03-01 |
| North Pacific Dental, Inc. | 1 | 1983-02-18 |
Most recent EIF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K940785 | Worldwide Dental, Inc. | MOUTH PROPS | 1994-10-05 | 225 |
| K873960 | Cheri Lewis, D.D.S. | LEWIS SAFE SLEEVE | 1987-12-04 | 67 |
| K830187 | Hematology Marketing Assoc. | FOCUS FLUID | 1983-03-01 | 41 |
| K830116 | North Pacific Dental, Inc. | SULCARINGS | 1983-02-18 | 38 |
Recalls for EIF devices
openFDA lists no recalls for product code EIF.
Frequently asked questions
What is FDA product code EIF?
EIF is the FDA product code for accessories, retractor, dental. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EIF?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EIF?
Across 4 cleared submissions the average was 93 days from receipt to decision (median 54).
Which companies have the most EIF clearances?
Worldwide Dental, Inc. (1); Cheri Lewis, D.D.S. (1); Hematology Marketing Assoc. (1); North Pacific Dental, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EIF
- Run a recall and safety report across every EIF manufacturer
- Watch product code EIF 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