| Primary Device ID | DIVO6670931 |
| NIH Device Record Key | ae4b0ac8-8a55-4da9-9a3e-343c512c6669 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bluephase PowerCure |
| Version Model Number | 667093 |
| Catalog Number | 667093 |
| Company DUNS | 448015938 |
| Company Name | IVOCLAR VIVADENT AKTIENGESELLSCHAFT |
| Device Count | 3 |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 Issuing Agency | Device ID |
|---|---|
| HIBCC | DIVO6670930 [Unit of Use] |
| HIBCC | DIVO6670931 [Primary] |
| EBZ | ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-02-26 |
| Device Publish Date | 2019-11-05 |
| DIVO6670931 | Bluephase PowerCure handpiece, Bluephase PowerCure battery, Bluephase PowerCure light guide |
| DIVO7409981 | Bluephase G4 handpiece, Bluephase G4 battery, Bluephase G4 light guide |
| DVIV691918BU1 | Blueph. PowerCure & System Kit mixed |
| DVIV668253BU1 | Bluephase PowerCure & System Kit syringe |
| 07615208461299 | Bluephase PowerCure 100-240V |
| 07615208461251 | Bluephase PowerCure 100-240V |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BLUEPHASE POWERCURE 79171560 4985929 Live/Registered |
IVOCLAR VIVADENT AG 2015-05-22 |