FDA product code EID: Syringe, Restorative And Impression Material
EID is the FDA product code for syringe, restorative and impression material. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 13 510(k) submissions under EID, from 10 different applicants. The average 510(k) review took 41 days (median 20). FDA has posted 1 recall for EID devices.
Classification
| Field | Value |
|---|---|
| Device name | Syringe, Restorative And Impression Material |
| 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 EID clearance
Top EID applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Centrix, Inc. | 2 | 1992-02-25 |
| Dentsply Intl. | 2 | 1987-09-16 |
| Espe GmbH (Us) | 2 | 1977-06-03 |
| Bio-Interfaces, Inc. | 1 | 1994-07-12 |
| Coltene, Inc. | 1 | 1986-10-30 |
5 more applicants have EID clearances. See the full list in Caduvo.
Most recent EID clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K941431 | Bio-Interfaces, Inc. | BONE GRAFT DELIVERY SYRINGES | 1994-07-12 | 110 |
| K913974 | Centrix, Inc. | ACCESS IMPRESSION BARREL | 1992-02-25 | 172 |
| K873153 | Dentsply Intl. | CAULK'S VPS CARTRIDGE SYSTEM | 1987-09-16 | 36 |
| K871937 | Dentsply Intl. | IMPRESSION SYRINGE | 1987-06-05 | 18 |
| K863998 | Coltene, Inc. | COLTENE JET-MIXER | 1986-10-30 | 16 |
Recalls for EID devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-12-14.
Frequently asked questions
What is FDA product code EID?
EID is the FDA product code for syringe, restorative and impression material. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EID?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EID?
Across 13 cleared submissions the average was 41 days from receipt to decision (median 20).
Which companies have the most EID clearances?
Centrix, Inc. (2); Dentsply Intl. (2); Espe GmbH (Us) (2); Bio-Interfaces, Inc. (1); Coltene, Inc. (1).
Have EID devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-12-14.
Next steps
- Run an FDA pathway report with predicate devices for product code EID
- Run a recall and safety report across every EID manufacturer
- Watch product code EID 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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