Calasept®Plus 1240100
GUDID 17310230000146
Directa AB
Calcium hydroxide dental cement| Primary Device ID | 17310230000146 |
| NIH Device Record Key | 32a29712-098f-41a1-807f-e8f28b5c5fc0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Calasept®Plus |
| Version Model Number | CalaseptPlus |
| Catalog Number | 1240100 |
| Company DUNS | 353954381 |
| Company Name | Directa AB |
| Device Count | 4 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 17310230000146 [Primary] |
| GS1 | 17310230000740 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K895508
FDA Product Code
| EJK | Liner, Cavity, Calcium Hydroxide |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-23 |
Devices Manufactured by Directa AB
| 17310230400304 - Ceramir Crown & Bridge QuikCap | 2024-04-05 Ceramir Crown & Bridge QuikCap Capsule |
| 17310230102772 - Ceramir Crown & Bridge QuikMix | 2024-04-05 Ceramir Crown & Bridge QuikMix Powder 15g |
| 17310230102789 - Ceramir Crown & Bridge QuikMix | 2024-04-05 Ceramir Crown & Bridge QuikMix Liquid 10g |
| 17310230400373 - Ceramir BIC QuikCap | 2024-04-05 Ceramir BIC QuikCap Capsule |
| 17310230400328 - Ceramir Crown & Bridge QuikMix | 2024-04-05 Ceramir Crown & Bridge QuikMix Kit |
| 17310230021318 - Luxator | 2022-12-15 17310231050416 17310231050423 17310231050430 17310231050447 |
| 17310230021325 - Luxator | 2022-12-15 17310231050461 17310231050430 17310231050416 17310231050454 17310231050478 17310231050447 17310231050423 |
| 17310230021332 - Luxator | 2022-12-15 17310231050485 17310231050461 17310231050430 17310231050416 17310231050454 |
Trademark Results [Calasept]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CALASEPT 80996215 0996215 Dead/Cancelled |
Scania Dental AB 0000-00-00 |
 CALASEPT 73776775 1627931 Live/Registered |
SCANIA DENTAL AB 1989-01-26 |
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