| Primary Device ID | E29963069 |
| NIH Device Record Key | 19af004f-4a83-46dc-b1f7-81ab4b1bfa62 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | myTines large |
| Version Model Number | 6306 |
| Company DUNS | 481461598 |
| Company Name | Polydentia SA |
| Device Count | 12 |
| 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 | false |
| 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 | E29963060 [Primary] |
| HIBCC | E29963069 [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 |
| E29950029 - wood wedges | 2025-06-24 |
| E2995018MN9 - Orange wood wedges | 2025-06-24 |
| E2995018PLUS9 - Orange wood wedges | 2025-06-24 |
| E2995018S9 - Orange wood wedges | 2025-06-24 |
| E29968900 - myQuickmat Prime Kit | 2025-06-24 |
| E29968919 - myRing Prime | 2025-06-24 |
| E29968929 - myTines Prime | 2025-06-24 |
| E29968939 - Quickmat Prime | 2025-06-24 |