| Primary Device ID | E29967359 |
| NIH Device Record Key | 1d8fa130-b044-453d-b5b7-def9540dfaec |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lumicontrast sectional matrices |
| Version Model Number | 6735 |
| Company DUNS | 481461598 |
| Company Name | Polydentia SA |
| Device Count | 70 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +41919462948 |
| info@polydentia.ch | |
| Phone | +41919462948 |
| info@polydentia.ch | |
| Phone | +41919462948 |
| info@polydentia.ch | |
| Phone | +41919462948 |
| info@polydentia.ch | |
| Phone | +41919462948 |
| info@polydentia.ch | |
| Phone | +41919462948 |
| info@polydentia.ch | |
| Phone | +41919462948 |
| info@polydentia.ch | |
| Phone | +41919462948 |
| info@polydentia.ch |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E29967350 [Primary] |
| HIBCC | E29967359 [Unit of Use] |
| DZN | Instruments, Dental Hand |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-14 |
| Device Publish Date | 2022-07-06 |
| E29967469 | 0.04 mm / 6.4 mm + Ext., 25 pcs. |
| E29967569 | 0.025 mm / 6.4mm +ext, 50 pcs. |
| E29967369 | 0.025 mm / 6.4 mm, 70 pcs. |
| E29967359 | 0.025 mm / 5 mm, 70 pcs. |
| E29967069 | 0.04 mm / 6.4 mm, 35 pcs. |
| E29967059 | 0.04 mm / 5 mm, 35 pcs. |