Transcend Bulk Fill Flowable Composite
Device Facts
| Record ID | K262228 |
|---|---|
| Device Name | Transcend Bulk Fill Flowable Composite |
| Applicant | Ultradent Products, Inc. |
| Product Code | EBF · Dental |
| Decision Date | Jul 1, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3690 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
Regulatory Classification
Identification
Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.
