| Primary Device ID | D800DSAD12516M6PIN0 |
| NIH Device Record Key | 1a82c51d-e6e8-4e02-8625-a9390e720614 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Denture Giginva Basic Mono Pink 125H16 SelfLock |
| Version Model Number | DSAD12516M6PIN |
| Company DUNS | 564251911 |
| Company Name | ZIRKONZAHN SRL |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D800DSAD12516M6PIN0 [Primary] |
| EBI | Resin, Denture, Relining, Repairing, Rebasing |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-14 |
| Device Publish Date | 2025-04-04 |
| D800DSAD12516BPI0 - Denture Giginva Basic Mono Blue Pink 125H16 | 2025-04-14 Content: 1 piece Height: 16 mm Gingiva-coloured resin with improved material properties in terms of high flexural strength and f |
| D800DSAD12516CPI0 - Denture Giginva Basic Mono Cherry Pink 125H16 | 2025-04-14 Content: 1 piece Height: 16 mm Gingiva-coloured resin with improved material properties in terms of high flexural strength and f |
| D800DSAD12516M6BPI0 - Denture Giginva Basic Mono Blue Pink 125H16 SelfLock | 2025-04-14 Content: 1 piece Height: 16 mm Gingiva-coloured resin with improved material properties in terms of high flexural strength and f |
| D800DSAD12516M6CPI0 - Denture Giginva Basic Mono Cherry Pink 125H16 SelfLock | 2025-04-14 Content: 1 piece Height: 16 mm Gingiva-coloured resin with improved material properties in terms of high flexural strength and f |
| D800DSAD12516M6PIN0 - Denture Giginva Basic Mono Pink 125H16 SelfLock | 2025-04-14Content: 1 piece Height: 16 mm Gingiva-coloured resin with improved material properties in terms of high flexural strength and fracture resistance. Specifically designed for the production of denture bases. |
| D800DSAD12516M6PIN0 - Denture Giginva Basic Mono Pink 125H16 SelfLock | 2025-04-14 Content: 1 piece Height: 16 mm Gingiva-coloured resin with improved material properties in terms of high flexural strength and f |
| D800DSAD12520BPI0 - Denture Giginva Basic Mono Blue Pink 125H20 | 2025-04-14 Content: 1 piece Height: 20 mm Gingiva-coloured resin with improved material properties in terms of high flexural strength and f |
| D800DSAD12520CPI0 - Denture Giginva Basic Mono Cherry Pink 125H20 | 2025-04-14 Content: 1 piece Height: 20 mm Gingiva-coloured resin with improved material properties in terms of high flexural strength and f |
| D800DSAD12520M6BPI0 - Denture Giginva Basic Mono Blue Pink 125H20 SelfLock | 2025-04-14 Content: 1 piece Height: 20 mm Gingiva-coloured resin with improved material properties in terms of high flexural strength and f |