| Primary Device ID | 17506338314845 |
| NIH Device Record Key | e6735bf6-1bc7-4cac-892e-023404a63d94 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Newtek, MDC Dental |
| Version Model Number | Anterior |
| Company DUNS | 811180298 |
| Company Name | MDC DENTAL |
| Device Count | 30 |
| 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 | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | 3338330333 |
| tecnovigilancia@dental.com.mx | |
| Phone | 3338330333 |
| tecnovigilancia@dental.com.mx | |
| Phone | 3338330333 |
| tecnovigilancia@dental.com.mx | |
| Phone | 3338330333 |
| tecnovigilancia@dental.com.mx | |
| Phone | 3338330333 |
| tecnovigilancia@dental.com.mx | |
| Phone | 3338330333 |
| tecnovigilancia@dental.com.mx | |
| Phone | 3338330333 |
| tecnovigilancia@dental.com.mx | |
| Phone | 3338330333 |
| tecnovigilancia@dental.com.mx | |
| Phone | 3338330333 |
| tecnovigilancia@dental.com.mx | |
| Phone | 3338330333 |
| tecnovigilancia@dental.com.mx | |
| Phone | 3338330333 |
| tecnovigilancia@dental.com.mx | |
| Phone | 3338330333 |
| tecnovigilancia@dental.com.mx | |
| Phone | 3338330333 |
| tecnovigilancia@dental.com.mx | |
| Phone | 3338330333 |
| tecnovigilancia@dental.com.mx | |
| Phone | 3338330333 |
| tecnovigilancia@dental.com.mx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07506338314848 [Primary] |
| GS1 | 17506338314845 [Unit of Use] |
| ELK | Teeth, Artificial, Backing And Facing |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-06 |
| Device Publish Date | 2022-09-28 |
| 17506338314852 | Box with 20 acrylic resin tooth tablets Posterior |
| 17506338314845 | Box with 30 tablets of acrylic resin tooth Anterior |