| Primary Device ID | J014600359991 |
| NIH Device Record Key | fad3ca09-1dbf-4122-9b11-1dde36faf416 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DYNAMIX MIXING TIPS (1 X 50) |
| Version Model Number | 60035999 |
| Catalog Number | 60035999 |
| Company DUNS | 315666321 |
| Company Name | Kulzer GmbH |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| 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 |
| Phone | +1(800)431-1785 |
| xxx@xxx.xxx | |
| Phone | +1(800)431-1785 |
| xxx@xxx.xxx | |
| Phone | +1(800)431-1785 |
| xxx@xxx.xxx | |
| Phone | +1(800)431-1785 |
| xxx@xxx.xxx | |
| Phone | +1(800)431-1785 |
| xxx@xxx.xxx | |
| Phone | +1(800)431-1785 |
| xxx@xxx.xxx | |
| Phone | +1(800)431-1785 |
| xxx@xxx.xxx | |
| Phone | +1(800)431-1785 |
| xxx@xxx.xxx | |
| Phone | +1(800)431-1785 |
| xxx@xxx.xxx | |
| Phone | +1(800)431-1785 |
| xxx@xxx.xxx | |
| Phone | +1(800)431-1785 |
| xxx@xxx.xxx | |
| Phone | +1(800)431-1785 |
| xxx@xxx.xxx | |
| Phone | +1(800)431-1785 |
| xxx@xxx.xxx |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | J014600359991 [Primary] |
| ELW | MATERIAL, IMPRESSION |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2024-10-30 |
| Device Publish Date | 2016-09-23 |
| J014600359991 | Dental Composite resin |
| J014400043530 | Syringe, restortative and impression material |