| Primary Device ID | EPRCD1001504 |
| NIH Device Record Key | 07e7f294-f3dd-49f5-a3ae-4fc0b4a58e26 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | printodent GR-19.1 OA I MSI |
| Version Model Number | ocean-blue, 1000g |
| Catalog Number | D1001504 |
| Company DUNS | 312947842 |
| Company Name | pro3dure medical GmbH |
| Device Count | 1 |
| 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 | 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 | EPRCD1001504 [Primary] |
| DYT | Maintainer, Space Preformed, Orthodontic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-06 |
| Device Publish Date | 2023-08-29 |
| EPRCD1000808 - printodent GR-10 guide I MSI | 2024-08-28 printodent GR-10 guide I MSI 1000g ; ocean-blue |
| EPRC6550 - IMPRIMO LC Splint comfort | 2024-05-14 |
| EPRC6575 - IMPRIMO LC Splint comfort MSI | 2024-05-14 |
| EPRCA0010200 - otosil IS-2 | 2023-10-26 IS-2 - 8 double cartridges of 2 x 25 ml ocean-blue / white-opaque |
| EPRCA0011000 - otosil PS-1 | 2023-10-26 otosil PS-1 2 x 300g ; Orange - White |
| EPRCA0034150 - otosil SL-1 | 2023-10-26 otosil SL-1 250 g; clear transparent |
| EPRCA0034151 - otosil SL-1 | 2023-10-26 otosil SL-1 100 g; clear transparent |
| EPRCA0034160 - otosil SL-1 I MSI | 2023-10-26 otosil SL-1 I MSI 250 g; clear transparent |