CLEARFIL MAJESTY™ ES-2
GUDID EKUR003145KA1
PLT (XWE)
KURARAY NORITAKE DENTAL INC.
Dental composite resin| Primary Device ID | EKUR003145KA1 |
| NIH Device Record Key | c09e3cbc-fdcd-484e-a296-3c255f6924dc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CLEARFIL MAJESTY™ ES-2 |
| Version Model Number | #3145-KA |
| Company DUNS | 697119498 |
| Company Name | KURARAY NORITAKE DENTAL INC. |
| Device Count | 10 |
| 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 | 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 | EKUR003145KA0 [Unit of Use] |
| HIBCC | EKUR003145KA1 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K121583
FDA Product Code
| EBF | Material, Tooth Shade, Resin |
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 | 2017-02-17 |
On-Brand Devices [CLEARFIL MAJESTY™ ES-2]
Trademark Results [CLEARFIL MAJESTY]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CLEARFIL MAJESTY 76650323 3333147 Live/Registered |
KURARAY CO., LTD. 2005-11-15 |
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