Denture Base Resin V2
Device Facts
| Record ID | K262300 |
|---|---|
| Device Name | Denture Base Resin V2 |
| Applicant | Formlabs Ohio, Inc. |
| Product Code | EBI · Dental |
| Decision Date | Jul 8, 2026 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 872.3760 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
Regulatory Classification
Identification
A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.
