| Primary Device ID | 17540208000339 |
| NIH Device Record Key | 2fc9ca5a-e717-4e61-b787-e2fa211caf51 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Select Supratemp |
| Version Model Number | TCB-ST-A3 |
| Catalog Number | TCB-ST-A3 |
| Company DUNS | 486717338 |
| Company Name | Zendo Direct AG |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature: max. 77°F (25°C) |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature: max. 77°F (25°C) |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature: max. 77°F (25°C) |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature: max. 77°F (25°C) |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature: max. 77°F (25°C) |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature: max. 77°F (25°C) |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature: max. 77°F (25°C) |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature: max. 77°F (25°C) |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature: max. 77°F (25°C) |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature: max. 77°F (25°C) |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature: max. 77°F (25°C) |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature: max. 77°F (25°C) |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature: max. 77°F (25°C) |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature: max. 77°F (25°C) |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature: max. 77°F (25°C) |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature: max. 77°F (25°C) |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature: max. 77°F (25°C) |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07540208000332 [Primary] |
| GS1 | 17540208000339 [Package] Contains: 07540208000332 Package: Carton [1 Units] In Commercial Distribution |
| EBG | Crown And Bridge, Temporary, Resin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-05-07 |
| Device Publish Date | 2018-04-04 |
| 17540208000339 - Select Supratemp | 2018-05-07Self cure temporary crown and bridge material - Shade: A3 |
| 17540208000339 - Select Supratemp | 2018-05-07 Self cure temporary crown and bridge material - Shade: A3 |
| 17540208000131 - Select NanoFill | 2018-03-29 Low shrink low abrasion light cure nano filled composite - Caps; Shade A2 |
| 17540208000254 - Select Flow | 2018-03-29 Light cure easy flowable microhybrid composite - Needle Tubes; Shade A1 |
| 17540208000261 - Select Flow | 2018-03-29 Light cure easy flowable microhybrid composite - Needle Tubes; Shade A2 |
| 17540208000278 - Select Flow | 2018-03-29 Light cure easy flowable microhybrid composite - Needle Tubes; Shade A3 |
| 17540208000308 - Select NanoFill | 2018-03-29 Low shrink low abrasion light cure nano filled composite - Caps; Shade A1 |
| 27540208000398 - MTA Capsules | 2018-03-29 Endodontic repair cement - Universal; 0.3 g capsules |
| 27540208000404 - MTA Firm- Normal Set | 2018-03-29 Endodontic repair cement - 0.25 g capsules |