510(k) K090457
K090457 is an FDA 510(k) premarket notification submitted by Pulpdent Corporation for the device "ORALUBE". The FDA issued a decision of Substantially Equivalent on May 21, 2009. The device falls under product code ONK (Oral Lubricant), a Class I device regulated under 21 CFR 880.6375. Pulpdent Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 21, 2009
- Date Received
- February 23, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oral Lubricant
- Device Class
- Class I
- Regulation Number
- 880.6375
- Review Panel
- DE
- Submission Type
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.