Oral Lubricant
The Oral Lubricant (product code ONK) is a Class 1 device regulated under 21 CFR 880.6375 in the General Hospital specialty (HO), cleared via 510(k) and reviewed by the Dental panel. It is intended for use adjacent to hard and soft oral tissue and the lips to prevent adhesion of dental cement, facilitate placement of a rubber dam, and prevent lip dryness and cracking during dental procedures. The device is eligible for third-party review and is not an implant or life-sustaining device.
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Basic Information
- Product Code
- ONK
- Device Class
- FDA class 1
- Regulation Number
- 880.6375
- Medical Specialty
- General Hospital
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K090457 | ORALUBE | May 21, 2009 | Substantially Equivalent | Pulpdent Corporation |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.