FDA product code EFW: Toothbrush, Manual
EFW is the FDA product code for toothbrush, manual. It is a Class I device, regulated under 21 CFR 872.6855 and reviewed by the Dental panel. FDA has cleared 49 510(k) submissions under EFW, from 42 different applicants. The average 510(k) review took 89 days (median 83). FDA has posted 5 recalls for EFW devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Toothbrush, Manual |
| Device class | Class I |
| Regulation | 21 CFR 872.6855 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every EFW clearance
Top EFW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Jdm Commodities | 4 | 1981-11-20 |
| Hoyt Laboratories | 3 | 1977-07-15 |
| U.S. Apatite Corp. | 2 | 1988-12-05 |
| Johnson & Johnson Professionals, Inc. | 2 | 1984-02-10 |
| Den Tek Oral Care, Inc. | 1 | 2013-07-15 |
37 more applicants have EFW clearances. See the full list in Caduvo.
Most recent EFW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K130186 | Den Tek Oral Care, Inc. | DENTEK EASY BRUSH WITH FLUORIDE | 2013-07-15 | 171 |
| K121165 | Beam Technologies, LLC | BEAM BRUSH/BEAM APP | 2012-06-21 | 65 |
| K102871 | Piave Spazzolificio S.P.A. | SILVER CARE ANITBACTERIAL TOOTHBRUSH | 2011-10-03 | 368 |
| K073224 | Procter & Gamble | ORAL-B SUB-BRAND MANUAL TOOTHBRUSH | 2008-02-06 | 83 |
| K021383 | Agion Technologies, LLC | ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL | 2002-07-17 | 76 |
Recalls for EFW devices
5 product recalls in 5 recall events; 2 initiated in the last five years and 3 still open. Most recent: 2025-12-26.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2022 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code EFW?
EFW is the FDA product code for toothbrush, manual. It is a Class I device, regulated under 21 CFR 872.6855 and reviewed by the Dental panel.
What device class is EFW?
Class I, regulation 21 CFR 872.6855. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EFW?
Across 49 cleared submissions the average was 89 days from receipt to decision (median 83).
Which companies have the most EFW clearances?
Jdm Commodities (4); Hoyt Laboratories (3); U.S. Apatite Corp. (2); Johnson & Johnson Professionals, Inc. (2); Den Tek Oral Care, Inc. (1).
Have EFW devices been recalled?
Yes: 5 product recalls across 5 recall events; the most recent began 2025-12-26.
Next steps
- Run an FDA pathway report with predicate devices for product code EFW
- Run a recall and safety report across every EFW manufacturer
- Watch product code EFW 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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