FDA product code EFT: Cleanser, Denture, Over The Counter
EFT is the FDA product code for cleanser, denture, over the counter. It is a Class I device, regulated under 21 CFR 872.3520 and reviewed by the Dental panel. FDA has cleared 26 510(k) submissions under EFT, from 24 different applicants. The average 510(k) review took 108 days (median 80). FDA has posted 3 recalls for EFT devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Cleanser, Denture, Over The Counter |
| Device class | Class I |
| Regulation | 21 CFR 872.3520 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EFT clearance
Top EFT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Combe, Inc. | 2 | 1994-08-10 |
| Lever Brothers Company, Inc. | 2 | 1985-04-29 |
| Oral Health Technologies, LLC | 1 | 2008-05-23 |
| Bonyf AG | 1 | 2006-06-02 |
| Dentsply Intl. | 1 | 2000-06-16 |
19 more applicants have EFT clearances. See the full list in Caduvo.
Most recent EFT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K080631 | Oral Health Technologies, LLC | CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER | 2008-05-23 | 79 |
| K051342 | Bonyf AG | MEDICAL INTERPOROUS | 2006-06-02 | 375 |
| K000996 | Dentsply Intl. | TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND | 2000-06-16 | 80 |
| K942203 | Combe, Inc. | OTC DENTURE CLEANSER | 1994-08-10 | 97 |
| K930337 | Fittydent-Altwirth & Schmitt GmbH | PROFAST(R)-DENTURE CLEANSER | 1993-09-07 | 228 |
Recalls for EFT devices
3 product recalls in 2 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2023-10-04.
| Year | Recalls |
|---|---|
| 2022 | 2 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code EFT?
EFT is the FDA product code for cleanser, denture, over the counter. It is a Class I device, regulated under 21 CFR 872.3520 and reviewed by the Dental panel.
What device class is EFT?
Class I, regulation 21 CFR 872.3520. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EFT?
Across 26 cleared submissions the average was 108 days from receipt to decision (median 80).
Which companies have the most EFT clearances?
Combe, Inc. (2); Lever Brothers Company, Inc. (2); Oral Health Technologies, LLC (1); Bonyf AG (1); Dentsply Intl. (1).
Have EFT devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2023-10-04.
Next steps
- Run an FDA pathway report with predicate devices for product code EFT
- Run a recall and safety report across every EFT manufacturer
- Watch product code EFT 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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