| Primary Device ID | E29969539 |
| NIH Device Record Key | 2f8d47e8-810e-4524-933a-40ef555f5eb7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Unica Proximal Deep |
| Version Model Number | 6953 |
| Catalog Number | 6953 |
| Company DUNS | 481461598 |
| Company Name | Polydentia SA |
| Device Count | 50 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E29969530 [Primary] |
| HIBCC | E29969539 [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 | 2025-05-07 |
| Device Publish Date | 2025-04-29 |
| E29969139 - Unica Proximal | 2025-05-07 anterior matrices |
| E29969149 - Unica Proximal | 2025-05-07 anterior matrices |
| E29969529 - Deep | 2025-05-07 anterior matrices |
| E29969539 - Unica Proximal Deep | 2025-05-07anterior matrices |
| E29969539 - Unica Proximal Deep | 2025-05-07 anterior matrices |
| E29963079 - myTines GO | 2024-08-27 extremities for myClip 2.0 and myRing Forte |
| E29958059 - QuickmatFIT | 2024-02-06 anatomical sectional matrices 0.04mm premolar |
| E29958069 - QuickmatFIT | 2024-02-06 anatomical sectional matrices 0.04mm molar |
| E29958359 - QuickmatFIT | 2024-02-06 anatomical sectional matrices 0.04mm premolar |