4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL
Device Facts
| Record ID | K920460 |
|---|---|
| Device Name | 4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL |
| Applicant | Pulpdent Corp. |
| Product Code | ELL · Dental |
| Decision Date | Apr 28, 1992 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3920 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A porcelain tooth is a prefabricated device made of porcelain powder for clinical use (§ 872.6660) intended for use in construction of fixed or removable prostheses, such as crowns and partial dentures.
