| Primary Device ID | J017BV13BK12CV30 |
| NIH Device Record Key | 5b95bf4d-6090-4122-9c6c-8c6e5c4da4ce |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VITA VM 9 |
| Version Model Number | BV13BK12CV3 |
| Company DUNS | 315165357 |
| Company Name | Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Phone | +1(800)8283839 |
| info@vitanorthamerica.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | J017BV13BK12CV30 [Primary] |
| EIH | POWDER, PORCELAIN |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-03-03 |
| Device Publish Date | 2020-02-24 |
| J017BV13BKS12V30 | VITAVM®13 BASIC KIT SMALL POWDER VITA SYSTEM 3D-MASTER® |
| J017BV13BKS12PV30 | VITAVM®13 BASIC KIT SMALL PASTE VITA SYSTEM 3D-MASTER® |
| J017BV13BKS12PCV30 | VITAVM®13 BASIC KIT SMALL PASTE VITA classical A1-D4® |
| J017BV13BKS12CV30 | VITAVM®13 BASIC KIT SMALL POWDER VITA classical A1-D4® |
| J017BV13BK12V30 | VITAVM®13 BASIC KIT POWDER VITA SYSTEM 3D-MASTER® |
| J017BV13BK12PV30 | VITAVM®13 BASIC KIT PASTE VITA SYSTEM 3D-MASTER® |
| J017BV13BK12PCV30 | VITAVM®13 BASIC KIT PASTE VITA classical A1-D4® |
| J017BV13BK12CV30 | VITAVM®13 BASIC KIT POWDER VITA classical A1-D4® |
| J017BV9OCKA2V40 | VM 9 ONE COLOR KIT A2 |
| J017BV9OCK2M2V50 | VM 9 One Color Kit 2M2 |
| J017BV9AOKV20 | VITAVM®9 ADD-ON KIT |
| J017B42214120 | VM9 EFF BONDER EB4 12g |
| J017B42211120 | VM9 EFF BONDER EB1 12g |