| Primary Device ID | 00856551007193 |
| NIH Device Record Key | 04570feb-3c89-4551-b057-555292ef0dc6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DENTCA Tray |
| Version Model Number | DENTCA Starter Kit |
| Company DUNS | 022455143 |
| Company Name | DENTCA, INC. |
| Device Count | 1 |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | +1(424)558-8726 |
| info@dentca.com | |
| Phone | +1(424)558-8726 |
| info@dentca.com | |
| Phone | +1(424)558-8726 |
| info@dentca.com | |
| Phone | +1(424)558-8726 |
| info@dentca.com | |
| Phone | +1(424)558-8726 |
| info@dentca.com | |
| Phone | +1(424)558-8726 |
| info@dentca.com | |
| Phone | +1(424)558-8726 |
| info@dentca.com | |
| Phone | +1(424)558-8726 |
| info@dentca.com | |
| Phone | +1(424)558-8726 |
| info@dentca.com | |
| Phone | +1(424)558-8726 |
| info@dentca.com | |
| Phone | +1(424)558-8726 |
| info@dentca.com | |
| Phone | +1(424)558-8726 |
| info@dentca.com | |
| Phone | +1(424)558-8726 |
| info@dentca.com | |
| Phone | +1(424)558-8726 |
| info@dentca.com | |
| Phone | +1(424)558-8726 |
| info@dentca.com | |
| Phone | +1(424)558-8726 |
| info@dentca.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856551007193 [Primary] |
| EHY | Tray, Impression, Preformed |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-11-11 |
| Device Publish Date | 2021-11-03 |
| 00856551007193 | Starter Kit |
| 00856551007186 | Single Arch Attachment (Upper & Lower) - Large & Extra Large |
| 00856551007179 | Single Arch Attachment (Upper & Lower) - Small & Medium |
| 00856551007162 | Tray - Small |
| 00856551007155 | Tray - Medium |
| 00856551007148 | Tray - Large |
| 00856551007131 | Tray - Extra Large |
| 00856551007124 | EZ Tracer |
| 00856551007117 | Jaw Gauge |
| 00856551007100 | Lip Ruler |