510(k) K090457
- Device
- ORALUBE
- Applicant
- PULPDENT CORPORATION
- 510(k) number
- K090457
- Product code
- ONK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-05-21
- Date received
- 2009-02-23
- Regulation
- 880.6375
- Classification name
- Oral Lubricant
- Medical specialty
- General Hospital
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KENNETH J BERK
- Address
- 80 Oakland St. Watertown MA US 02472 02472
FDA Registration Numbers#
- 3012996495
Source Documents#
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases