| Primary Device ID | DIVO684551AN0 |
| NIH Device Record Key | 78d6bb29-2b9c-48f5-87ae-14a3593a1e26 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OptraGloss |
| Version Model Number | 684551AN |
| Catalog Number | 684551AN |
| Company DUNS | 448015938 |
| Company Name | IVOCLAR VIVADENT AKTIENGESELLSCHAFT |
| Device Count | 14 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 Issuing Agency | Device ID |
|---|---|
| HIBCC | DIVO684551AN0 [Unit of Use] |
| HIBCC | DIVO684551AN1 [Primary] |
| HIBCC | DVIV684551AN1 [Primary] |
| EHJ | DISK, ABRASIVE |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-03 |
| Device Publish Date | 2020-08-26 |
| DIVO706172WW1 | OptraGloss Flame PP, OptraGloss Kelch PP, OptraGloss Linse PP, OptraGloss Flame HP, OptraGloss K |
| DIVO684555AN0 | OptraGloss Flame PP, OptraGloss Cup PP, OptraGloss Lens PP, OptraGloss Flame HP, OptraGloss Cup |
| DIVO684554AN0 | OptraGloss Refill Flame HP |
| DIVO684553AN0 | OptraGloss Refill Flame PP |
| DIVO684552AN0 | OptraGloss Refill Lens HP |
| DIVO684551AN0 | OptraGloss Refill Lens VP |
| DIVO684550AN0 | OptraGloss Refill Cup HP |
| DIVO684549AN0 | OptraGloss Refill Cup PP |
| DIVO684548AN0 | OptraGloss Flame PP, OptraGloss Cup PP, OptraGloss Lens PP, OptraGloss Flame HP, OptraGloss Cup |
| DVIV701792WW0 | OptraGloss Flame PP, OptraGloss Kelch PP, OptraGloss Linse PP, OptraGloss Flame HP, OptraGloss K |
| DIVO742102WW0 | OptraGloss Refill Spiral Wheel HP, Instr. for use OptraGloss WW |
| DVIV706172WW1 | OptraGloss Flame PP, OptraGloss Kelch PP, OptraGloss Linse PP, OptraGloss Flame HP, OptraGloss K |
| 07615208472622 | OptraGloss Refill Lens HP |
| 07615208458077 | OptraGloss Test Pack 2 |
| DVIV684548AN1 | OptraGloss Assortment |
| 07615208472592 | OptraGloss Refill Cup PP |
| 07615208472608 | OptraGloss Refill Cup HP |
| 07615208472615 | OptraGloss Refill Lens PP |
| 07615208472639 | OptraGloss Refill Flame PP |
| 07615208472646 | OptraGloss Refill Flame HP |
| 07615208294613 | OptraGloss Ceramic Kit |
| 07615208292824 | OptraGloss Composite Kit |
| 07615208472707 | OptraGloss Refill Spiral Wheel HP |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() OPTRAGLOSS 88284685 not registered Live/Pending |
Ivoclar Vivadent, Inc. 2019-01-31 |