| Primary Device ID | E29958569 |
| NIH Device Record Key | b318c1b6-3d74-458e-a8de-3e2cf99b7ecc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QuickmatFIT |
| Version Model Number | 5856 |
| Catalog Number | 5856 |
| 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 | E29958560 [Primary] |
| HIBCC | E29958569 [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 | 2024-02-06 |
| Device Publish Date | 2024-01-29 |
| E29958569 | anatomical sectional matrices 0.04mm molar deep |
| E29958469 | anatomical sectional matrices 0.04mm molar deep |
| E29958369 | anatomical sectional matrices 0.04mm molar |
| E29958359 | anatomical sectional matrices 0.04mm premolar |
| E29958069 | anatomical sectional matrices 0.04mm molar |
| E29958059 | anatomical sectional matrices 0.04mm premolar |