| Primary Device ID | EDD165514070 |
| NIH Device Record Key | 42925e0c-acff-41d5-87e5-f548b9c05991 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | inCoris |
| Version Model Number | inCoris TZI C disc 16 mm A1 |
| Catalog Number | EDD165514070 |
| Company DUNS | 329532225 |
| Company Name | DeguDent GmbH |
| 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 | true |
| 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 | EDD165514070 [Primary] |
| EIH | POWDER, PORCELAIN |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-25 |
| Device Publish Date | 2024-11-16 |
| EDD165514640 | inCoris TZI C disc 22 mm A3 |
| EDD165514560 | inCoris TZI C disc 22 mm A2 |
| EDD165514310 | inCoris TZI C disc 16 mm A3.5 |
| EDD165514230 | inCoris TZI C disc 16 mm A3 |
| EDD165514150 | inCoris TZI C disc 16 mm A2 |
| EDD165514070 | inCoris TZI C disc 16 mm A1 |
| EDD165513570 | inCoris TZI disc 22 mm BL |
| EDD165513400 | inCoris TZI disc 16 mm BL |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() INCORIS 79030082 3352639 Live/Registered |
Sirona Dental Systems GmbH 2006-08-07 |