HELIOSEAL
Device Facts
| Record ID | K813015 |
|---|---|
| Device Name | HELIOSEAL |
| Applicant | Vivadent (Usa), Inc. |
| Product Code | EBC · Dental |
| Decision Date | Dec 2, 1981 |
| 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.
