ZENITH 40% PHOSPHORIC ACID GEL
Device Facts
| Record ID | K890464 |
|---|---|
| Device Name | ZENITH 40% PHOSPHORIC ACID GEL |
| Applicant | Foremost Dental Mfg., Inc. |
| Product Code | EBC · Dental |
| Decision Date | Feb 13, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3765 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.
