FDA product code EBR: Unit, Suction Operatory
EBR is the FDA product code for unit, suction operatory. It is a Class I device, regulated under 21 CFR 872.6640 and reviewed by the Dental panel. FDA has cleared 3 510(k) submissions under EBR, from 3 different applicants. The average 510(k) review took 204 days (median 65). FDA has posted 3 recalls for EBR devices.
Classification
| Field | Value |
|---|---|
| Device name | Unit, Suction Operatory |
| Device class | Class I |
| Regulation | 21 CFR 872.6640 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EBR clearance
Top EBR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| A-Dec, Inc. | 1 | 1994-04-11 |
| Nissho Iwai American Corp. | 1 | 1986-03-12 |
| W.H. Wall, D.D.S. | 1 | 1977-04-08 |
Most recent EBR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K925367 | A-Dec, Inc. | A-DEC 7284 CUSPIDOR, CASCADE | 1994-04-11 | 537 |
| K860058 | Nissho Iwai American Corp. | DENPAX | 1986-03-12 | 65 |
| K770600 | W.H. Wall, D.D.S. | OROPHARYNGEAL SUCTION AIRWAY | 1977-04-08 | 10 |
Recalls for EBR devices
3 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2004-04-13.
Frequently asked questions
What is FDA product code EBR?
EBR is the FDA product code for unit, suction operatory. It is a Class I device, regulated under 21 CFR 872.6640 and reviewed by the Dental panel.
What device class is EBR?
Class I, regulation 21 CFR 872.6640. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EBR?
Across 3 cleared submissions the average was 204 days from receipt to decision (median 65).
Which companies have the most EBR clearances?
A-Dec, Inc. (1); Nissho Iwai American Corp. (1); W.H. Wall, D.D.S. (1).
Have EBR devices been recalled?
Yes: 3 product recalls across 1 recall events; the most recent began 2004-04-13.
Next steps
- Run an FDA pathway report with predicate devices for product code EBR
- Run a recall and safety report across every EBR manufacturer
- Watch product code EBR 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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