FDA product code ONK: Oral Lubricant
ONK is the FDA product code for oral lubricant. It is a Class I device, regulated under 21 CFR 880.6375 and reviewed by the Dental panel. FDA has cleared 1 510(k) submission under ONK. The average 510(k) review took 87 days (median 87).
Definition
An oral lubricant to be used adjacent to hard and soft tissue and the lips to prevent adherence of dental cement; Placement of a rubber dam; And to prevent the lips from drying and cracking during dental procedures.
Classification
| Field | Value |
|---|---|
| Device name | Oral Lubricant |
| Device class | Class I |
| Regulation | 21 CFR 880.6375 |
| Review panel | DE — Dental |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every ONK clearance
Top ONK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pulpdent Corporation | 1 | 2009-05-21 |
Most recent ONK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K090457 | Pulpdent Corporation | ORALUBE | 2009-05-21 | 87 |
Recalls for ONK devices
openFDA lists no recalls for product code ONK.
Frequently asked questions
What is FDA product code ONK?
ONK is the FDA product code for oral lubricant. It is a Class I device, regulated under 21 CFR 880.6375 and reviewed by the Dental panel.
What device class is ONK?
Class I, regulation 21 CFR 880.6375. Typical premarket route: 510(k).
How long does a 510(k) take for product code ONK?
Across 1 cleared submissions the average was 87 days from receipt to decision (median 87).
Which companies have the most ONK clearances?
Pulpdent Corporation (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ONK
- Run a recall and safety report across every ONK manufacturer
- Watch product code ONK 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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