510(k) K830491
- Device
- Johnson & Johnson Opaque Color Modifi
- Applicant
- JOHNSON & JOHNSON PROFESSIONALS, INC.
- 510(k) number
- K830491
- Product code
- EBE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-03-17
- Date received
- 1983-02-15
- Regulation
- 872.3300
- Classification name
- Coating, Denture Hydrophilic, Resin
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 325 Paramount Dr. Raynham MA US 02767 02767
FDA Registration Numbers#
- 3023346365
- 3043303267
- 3008648418
Source Documents#
510(k) summary PDF not indicated by FDA