ONK
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Oral Lubricant
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6375
- Medical specialty
- General Hospital
- Flags
- Third-party review eligible
- FDA 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.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| ORALUBE (K090457) | Pulpdent Corporation | 2009-05-21 | + Add |
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