FDA product code OAJ: Catheter, Drainage, Intraoral/Extraoral
OAJ is the FDA product code for catheter, drainage, intraoral/extraoral. It is a Class I device, regulated under 21 CFR 878.4200 and reviewed by the Dental panel. FDA has cleared 1 510(k) submission under OAJ. The average 510(k) review took 333 days (median 333).
Definition
To allow continuous drainage of saliva and/or fluid irrigation of the salivary duct as well as assisting in maintaining duct patency during the healing process following removal of salivary gland stones for temporary insertion into the salivary gland, whether orally or through the cheek following endoscopic or surgical removal of salivary gland stones
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Drainage, Intraoral/Extraoral |
| Device class | Class I |
| Regulation | 21 CFR 878.4200 |
| Review panel | DE — Dental |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every OAJ clearance
Top OAJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sialo Technology, Ltd. | 1 | 2008-07-18 |
Most recent OAJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K072334 | Sialo Technology, Ltd. | SIALO DRAIN | 2008-07-18 | 333 |
Recalls for OAJ devices
openFDA lists no recalls for product code OAJ.
Frequently asked questions
What is FDA product code OAJ?
OAJ is the FDA product code for catheter, drainage, intraoral/extraoral. It is a Class I device, regulated under 21 CFR 878.4200 and reviewed by the Dental panel.
What device class is OAJ?
Class I, regulation 21 CFR 878.4200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code OAJ?
Across 1 cleared submissions the average was 333 days from receipt to decision (median 333).
Which companies have the most OAJ clearances?
Sialo Technology, Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OAJ
- Run a recall and safety report across every OAJ manufacturer
- Watch product code OAJ 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.
All Dental product codes · FDA product code lookup · 510(k) database search · 510(k) review times