| Primary Device ID | J017EENST0620 |
| NIH Device Record Key | a89440ac-308e-4190-a577-d68d69e7d6e4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VITA ENAMIC STAINS |
| Version Model Number | EENST062 |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Phone | +1(800)8283839 |
| info@vitanorthamerica.com | |
| Phone | +1(800)8283839 |
| info@vitanorthamerica.com | |
| Phone | +1(800)8283839 |
| info@vitanorthamerica.com | |
| Phone | +1(800)8283839 |
| info@vitanorthamerica.com | |
| Phone | +1(800)8283839 |
| info@vitanorthamerica.com | |
| Phone | +1(800)8283839 |
| info@vitanorthamerica.com | |
| Phone | +1(800)8283839 |
| info@vitanorthamerica.com | |
| Phone | +1(800)8283839 |
| info@vitanorthamerica.com | |
| Phone | +1(800)8283839 |
| info@vitanorthamerica.com | |
| Phone | +1(800)8283839 |
| info@vitanorthamerica.com | |
| Phone | +1(800)8283839 |
| info@vitanorthamerica.com | |
| Phone | +1(800)8283839 |
| info@vitanorthamerica.com | |
| Phone | +1(800)8283839 |
| info@vitanorthamerica.com | |
| Phone | +1(800)8283839 |
| info@vitanorthamerica.com | |
| Phone | +1(800)8283839 |
| info@vitanorthamerica.com | |
| Phone | +1(800)8283839 |
| info@vitanorthamerica.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | J017EENST0620 [Primary] |
| EBF | MATERIAL, TOOTH SHADE, RESIN |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2025-02-25 |
| Device Publish Date | 2017-02-18 |
| J017EENSTKIT0 | VITA ENAMIC® STAINS KIT |
| J017EENSTG200 | VITA ENAMIC GLAZE, 20 ml inkl. 1 Packung |
| J017EENST0620 | VITA ENAMIC STAIN 6, black, 2 g |
| J017EENST0520 | VITA ENAMIC STAIN 5, blue, 2 g |
| J017EENST0420 | VITA ENAMIC STAIN 4, khaki, 2 g |
| J017EENST0320 | VITA ENAMIC STAIN 3, brown, 2 g |
| J017EENST0220 | VITA ENAMIC STAIN 2, corn, 2 g |
| J017EENST0120 | VITA ENAMIC STAIN 1, white, 2 g |