ORALUBE
Oral Lubricant
PULPDENT CORPORATION
The following data is part of a premarket notification filed by Pulpdent Corporation with the FDA for Oralube.
Pre-market Notification Details
| Device ID | K090457 |
| 510k Number | K090457 |
| Device Name: | ORALUBE |
| Classification | Oral Lubricant |
| Applicant | PULPDENT CORPORATION 80 OAKLAND ST. Watertown, MA 02472 |
| Contact | Kenneth J Berk |
| Correspondent | Kenneth J Berk PULPDENT CORPORATION 80 OAKLAND ST. Watertown, MA 02472 |
| Product Code | ONK |
| CFR Regulation Number | 880.6375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-23 |
| Decision Date | 2009-05-21 |
| Summary: | summary |
Trademark Results [ORALUBE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORALUBE 76004345 not registered Dead/Abandoned |
ORASYSTEMS, LLC 2000-03-20 |
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