CERABIEN™ MiLai
GUDID EKUR1090071KA0
10G LTx
KURARAY NORITAKE DENTAL INC.
Dental appliance fabrication material, ceramic| Primary Device ID | EKUR1090071KA0 |
| NIH Device Record Key | 1830426e-be40-4ce1-ab09-14f6fef9db34 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CERABIEN™ MiLai |
| Version Model Number | 109-0071KA |
| Company DUNS | 697119498 |
| Company Name | KURARAY NORITAKE DENTAL INC. |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EKUR1090071KA0 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K213147
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 | 2022-05-30 |
| Device Publish Date | 2022-05-20 |
On-Brand Devices [CERABIEN™ MiLai]
Trademark Results [CERABIEN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CERABIEN 75907452 2528389 Live/Registered |
Noritake Co., Limited 2000-02-01 |
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