FDA product code EEF: Clamp, Rubber Dam
EEF is the FDA product code for clamp, rubber dam. It is a Class I device, regulated under 21 CFR 872.6300 and reviewed by the Dental panel. FDA has cleared 3 510(k) submissions under EEF, from 3 different applicants. The average 510(k) review took 72 days (median 88). FDA has posted 1 recall for EEF devices.
Classification
| Field | Value |
|---|---|
| Device name | Clamp, Rubber Dam |
| Device class | Class I |
| Regulation | 21 CFR 872.6300 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every EEF clearance
Top EEF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sybron Dental Specialties, Inc. | 1 | 2007-09-21 |
| Bay Technical Products, Inc. | 1 | 1992-02-14 |
| Hygienic Dental Mfg., Co., The | 1 | 1978-05-12 |
Most recent EEF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K071615 | Sybron Dental Specialties, Inc. | FIXAFLOSS | 2007-09-21 | 100 |
| K915207 | Bay Technical Products, Inc. | DISPOSABLE RADIOLUCENT RUBBER DAM CLAMP | 1992-02-14 | 88 |
| K780744 | Hygienic Dental Mfg., Co., The | BRINKER TISSUE RETRACTORS | 1978-05-12 | 29 |
Recalls for EEF devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-04-21.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code EEF?
EEF is the FDA product code for clamp, rubber dam. It is a Class I device, regulated under 21 CFR 872.6300 and reviewed by the Dental panel.
What device class is EEF?
Class I, regulation 21 CFR 872.6300. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EEF?
Across 3 cleared submissions the average was 72 days from receipt to decision (median 88).
Which companies have the most EEF clearances?
Sybron Dental Specialties, Inc. (1); Bay Technical Products, Inc. (1); Hygienic Dental Mfg., Co., The (1).
Have EEF devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2021-04-21.
Next steps
- Run an FDA pathway report with predicate devices for product code EEF
- Run a recall and safety report across every EEF manufacturer
- Watch product code EEF 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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