FDA product code EFN: Cotton, Roll
EFN is the FDA product code for cotton, roll. It is a Class I device, regulated under 21 CFR 872.6050 and reviewed by the Dental panel. FDA has cleared 14 510(k) submissions under EFN, from 13 different applicants. The average 510(k) review took 65 days (median 32). FDA has posted 2 recalls for EFN devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Cotton, Roll |
| Device class | Class I |
| Regulation | 21 CFR 872.6050 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every EFN clearance
Top EFN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Intl. Verbandstoff-Fabrik Schaffhau | 2 | 1986-08-06 |
| American Silk Sutures, Inc. | 1 | 1987-12-04 |
| Medgroup Enterprises, Inc. | 1 | 1987-04-30 |
| The Medical Group, Inc. | 1 | 1986-10-27 |
| Cross Country Paper Products Corp. | 1 | 1986-07-10 |
8 more applicants have EFN clearances. See the full list in Caduvo.
Most recent EFN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K872810 | American Silk Sutures, Inc. | STRUNG DENTAL ROLLS | 1987-12-04 | 143 |
| K871464 | Medgroup Enterprises, Inc. | MEDGROUP ENTERPRISES COTTON GAUZE SPONGES-NON STER | 1987-04-30 | 16 |
| K863764 | The Medical Group, Inc. | COTTON ROLLS, NON-STERILE | 1986-10-27 | 32 |
| K861338 | Intl. Verbandstoff-Fabrik Schaffhau | DENTAL COTTON ROLLS, STERILE AND NON-STERILE | 1986-08-06 | 121 |
| K861727 | Cross Country Paper Products Corp. | COTTON FILLED GAUZE SPONGES 2 X 2 | 1986-07-10 | 65 |
Recalls for EFN devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-08-02.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code EFN?
EFN is the FDA product code for cotton, roll. It is a Class I device, regulated under 21 CFR 872.6050 and reviewed by the Dental panel.
What device class is EFN?
Class I, regulation 21 CFR 872.6050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EFN?
Across 14 cleared submissions the average was 65 days from receipt to decision (median 32).
Which companies have the most EFN clearances?
Intl. Verbandstoff-Fabrik Schaffhau (2); American Silk Sutures, Inc. (1); Medgroup Enterprises, Inc. (1); The Medical Group, Inc. (1); Cross Country Paper Products Corp. (1).
Have EFN devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2022-08-02.
Next steps
- Run an FDA pathway report with predicate devices for product code EFN
- Run a recall and safety report across every EFN manufacturer
- Watch product code EFN 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