FDA product code EIB: Syringe, Irrigating (Dental)
EIB is the FDA product code for syringe, irrigating (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 EIB, from 4 different applicants. The average 510(k) review took 170 days (median 162).
Classification
| Field | Value |
|---|---|
| Device name | Syringe, Irrigating (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 EIB clearance
Top EIB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cp Medical | 1 | 1991-11-20 |
| Allergan, Inc. | 1 | 1988-01-14 |
| Western Advanced Technology, Inc. | 1 | 1983-07-12 |
| Xomed, Inc. | 1 | 1976-09-21 |
Most recent EIB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K911118 | Cp Medical | DTF-1000LL,DTF-1000 | 1991-11-20 | 253 |
| K874543 | Allergan, Inc. | MODEL OPO-32 IRRIGATION SLEEVE | 1988-01-14 | 72 |
| K822411 | Western Advanced Technology, Inc. | SYSTEM 80 FACEPLATE-IN-THE-EAR #F1 | 1983-07-12 | 336 |
| K760570 | Xomed, Inc. | ROBINSON MIDDLE EAR PROSTHESIS | 1976-09-21 | 20 |
Recalls for EIB devices
openFDA lists no recalls for product code EIB.
Frequently asked questions
What is FDA product code EIB?
EIB is the FDA product code for syringe, irrigating (dental). It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EIB?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EIB?
Across 4 cleared submissions the average was 170 days from receipt to decision (median 162).
Which companies have the most EIB clearances?
Cp Medical (1); Allergan, Inc. (1); Western Advanced Technology, Inc. (1); Xomed, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EIB
- Run a recall and safety report across every EIB manufacturer
- Watch product code EIB 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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