FDA product code EIG: Retractor, All Types
EIG is the FDA product code for retractor, all types. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 8 510(k) submissions under EIG, from 7 different applicants. The average 510(k) review took 46 days (median 42).
Classification
| Field | Value |
|---|---|
| Device name | Retractor, All Types |
| 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 EIG clearance
Top EIG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Septodont, Inc. | 2 | 1976-11-19 |
| Ultradent Products, Inc. | 1 | 1997-06-03 |
| Downs Surgical , Ltd. | 1 | 1986-02-25 |
| Universal Prosthetics, Inc. | 1 | 1983-09-26 |
| Pacific Dental Corp. | 1 | 1982-07-06 |
2 more applicants have EIG clearances. See the full list in Caduvo.
Most recent EIG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K971284 | Ultradent Products, Inc. | OPALDAM | 1997-06-03 | 57 |
| K854711 | Downs Surgical , Ltd. | FIBRELIGHT ILLUMINATING ORAL RETRACTORS | 1986-02-25 | 95 |
| K832366 | Universal Prosthetics, Inc. | ZOLLER BURNED LIP CONFORMER | 1983-09-26 | 70 |
| K821784 | Pacific Dental Corp. | BEACH GINGIVAL RETRACTION INSTR. TYPE B | 1982-07-06 | 19 |
| K771973 | Den-Mat Corp. | GINGITRACT | 1977-11-07 | 21 |
Recalls for EIG devices
openFDA lists no recalls for product code EIG.
Frequently asked questions
What is FDA product code EIG?
EIG is the FDA product code for retractor, all types. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EIG?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EIG?
Across 8 cleared submissions the average was 46 days from receipt to decision (median 42).
Which companies have the most EIG clearances?
Septodont, Inc. (2); Ultradent Products, Inc. (1); Downs Surgical , Ltd. (1); Universal Prosthetics, Inc. (1); Pacific Dental Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EIG
- Run a recall and safety report across every EIG manufacturer
- Watch product code EIG 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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