FDA product code ECB: Unit, Syringe, Air And/Or Water
ECB is the FDA product code for unit, syringe, air and/or water. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 12 510(k) submissions under ECB, from 12 different applicants. The average 510(k) review took 128 days (median 84).
Classification
| Field | Value |
|---|---|
| Device name | Unit, Syringe, Air And/Or Water |
| Device class | Class I |
| Regulation | 21 CFR 872.4565 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every ECB clearance
Top ECB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bull Frog Mfg. Co. | 1 | 1994-08-23 |
| Western M/D, Inc. | 1 | 1994-03-07 |
| A-Dec, Inc. | 1 | 1993-11-29 |
| Riskontrol | 1 | 1993-04-05 |
| Smith & Nephew, Inc. | 1 | 1992-09-15 |
7 more applicants have ECB clearances. See the full list in Caduvo.
Most recent ECB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K942519 | Bull Frog Mfg. Co. | UNI-SYRINGE, UNI-TIP AND ACCESS SYRINGE TIPS | 1994-08-23 | 89 |
| K931772 | Western M/D, Inc. | SURETIP SYRINGE TIP COVER | 1994-03-07 | 332 |
| K931137 | A-Dec, Inc. | DENTAL SYRINGE TIP | 1993-11-29 | 269 |
| K923876 | Riskontrol | RISKONTROL SINGLE USE | 1993-04-05 | 245 |
| K923285 | Smith & Nephew, Inc. | PRO-TIP DISPOSABLE 3/1 SYRINGE NOZZLE | 1992-09-15 | 71 |
Recalls for ECB devices
openFDA lists no recalls for product code ECB.
Frequently asked questions
What is FDA product code ECB?
ECB is the FDA product code for unit, syringe, air and/or water. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is ECB?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ECB?
Across 12 cleared submissions the average was 128 days from receipt to decision (median 84).
Which companies have the most ECB clearances?
Bull Frog Mfg. Co. (1); Western M/D, Inc. (1); A-Dec, Inc. (1); Riskontrol (1); Smith & Nephew, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ECB
- Run a recall and safety report across every ECB manufacturer
- Watch product code ECB 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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