CLEARFIL MAJESTY™ ES-2
GUDID EKUR003126KA1
PLT (XW)
KURARAY NORITAKE DENTAL INC.
Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin| Primary Device ID | EKUR003126KA1 |
| NIH Device Record Key | 03a097e4-5f21-4da8-ade6-198391ecbdee |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CLEARFIL MAJESTY™ ES-2 |
| Version Model Number | #3126-KA |
| Company DUNS | 697119498 |
| Company Name | KURARAY NORITAKE DENTAL INC. |
| Device Count | 20 |
| 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 | EKUR003126KA0 [Unit of Use] |
| HIBCC | EKUR003126KA1 [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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