Estar-Z
GUDID 08800121764414
Osstem Implant Co.,Ltd.
Custom-made dental crown, ceramic| Primary Device ID | 08800121764414 |
| NIH Device Record Key | 87e93815-d81c-4a3e-87a2-9cad46f87da5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Estar-Z |
| Version Model Number | ZTC2022T |
| Company DUNS | 694893867 |
| Company Name | Osstem Implant Co.,Ltd. |
| 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 | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | 08800121764414 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K210097
FDA Product Code
| EIH | Powder, Porcelain |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-04 |
| Device Publish Date | 2024-08-27 |
On-Brand Devices [Estar-Z]
Trademark Results [Estar-Z]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ESTAR-Z 79308895 not registered Live/Pending |
OSSTEMIMPLANT CO., LTD. 2021-03-16 |
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