FDA product code EFS: Unit, Oral Irrigation
EFS is the FDA product code for unit, oral irrigation. It is a Class I device, regulated under 21 CFR 872.6510 and reviewed by the Dental panel. FDA has cleared 47 510(k) submissions under EFS, from 35 different applicants. The average 510(k) review took 109 days (median 75).
Classification
| Field | Value |
|---|---|
| Device name | Unit, Oral Irrigation |
| Device class | Class I |
| Regulation | 21 CFR 872.6510 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EFS clearance
Top EFS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Teledyne Water Pik | 5 | 1993-09-20 |
| Teledyne, Inc. | 4 | 1986-08-26 |
| Dentsply Intl. | 3 | 1988-02-23 |
| Vipont Laboratories, Inc. | 3 | 1984-03-30 |
| Micro Motors, Inc. | 2 | 1991-01-25 |
30 more applicants have EFS clearances. See the full list in Caduvo.
Most recent EFS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K023232 | Smartpractice | SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE | 2002-12-11 | 75 |
| K001493 | Air Force, Inc. | DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001 | 2000-10-25 | 166 |
| K983374 | Midian Intl. | AGATHA-A-H2010 | 1998-12-23 | 89 |
| K964810 | Ultradent Products, Inc. | DERMADAM | 1997-02-10 | 73 |
| K952234 | Cottrell, Ltd. | BARRIER ALL FILM | 1995-07-31 | 80 |
Recalls for EFS devices
openFDA lists no recalls for product code EFS.
Frequently asked questions
What is FDA product code EFS?
EFS is the FDA product code for unit, oral irrigation. It is a Class I device, regulated under 21 CFR 872.6510 and reviewed by the Dental panel.
What device class is EFS?
Class I, regulation 21 CFR 872.6510. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EFS?
Across 47 cleared submissions the average was 109 days from receipt to decision (median 75).
Which companies have the most EFS clearances?
Teledyne Water Pik (5); Teledyne, Inc. (4); Dentsply Intl. (3); Vipont Laboratories, Inc. (3); Micro Motors, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code EFS
- Run a recall and safety report across every EFS manufacturer
- Watch product code EFS 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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