| Primary Device ID | 00817340022285 |
| NIH Device Record Key | 8a8b4db4-f559-4ffa-8822-5b89bd46a3b9 |
| Commercial Distribution Discontinuation | 2020-01-23 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Imagine Zirconia |
| Version Model Number | Imagine Micro Layering Kit |
| Catalog Number | IM278 |
| Company DUNS | 060018587 |
| Company Name | JENSEN INDUSTRIES INC. |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817340022285 [Primary] |
| EIH | Powder, Porcelain |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-01-27 |
| Device Publish Date | 2016-09-23 |
| 00817340023206 | Imagine Zr Multilayered B3 98x14mm Disc |
| 00817340023190 | Imagine Zr Multilayered B2 98x14mm Disc |
| 00817340023183 | Imagine Zr Multilayered B1 98x14mm Disc |
| 00817340023176 | Imagine Zr Multilayered A3.5 98x14mm Disc |
| 00817340023169 | Imagine Zr Multilayered A4 98x14mm Disc |
| 00817340023152 | Imagine Zr Multilayered A3 98x14mm Disc |
| 00817340023145 | Imagine Zr Multilayered A2 98x14mm Disc |
| 00817340023138 | Imagine Zr Multilayered A1 98x14mm Disc |
| 00817340022285 | Imagine Micro Layering Kit |
| 00817340022278 | Imagine Zr Unshaded 98x22mm Disc |
| 00817340022261 | Imagine Zr Unshaded 98x12mm Disc |
| 00817340022254 | Imagine Zr Unshaded 18mm Frame 2pk |
| 00817340022247 | Imagine Zr Unshaded 14mm Frame 2pk |
| 00817340022230 | Imagine Zr Unshaded 98x18mm Disc |
| 00817340022223 | Imagine Zr Unshaded 98x14mm Disc |
| 00817340025637 | Imagine Zr Multilayered BL 98x14mm Disc |
| 00817340025620 | Imagine Zr Multilayered D4 98x14mm Disc |
| 00817340025613 | Imagine Zr Multilayered D3 98x14mm Disc |
| 00817340025606 | Imagine Zr Multilayered D2 98x14mm Disc |
| 00817340025590 | Imagine Zr Multilayered C4 98x14mm Disc |
| 00817340025583 | Imagine Zr Multilayered C3 98x14mm Disc |
| 00817340025576 | Imagine Zr Multilayered C2 98x14mm Disc |
| 00817340025569 | Imagine Zr Multilayered C1 98x14mm Disc |
| 00817340025552 | Imagine Zr Multilayered B4 98x14mm Disc |
| 00817340023282 | Imagine Zr Multilayered B3 98x18mm Disc |
| 00817340023275 | Imagine Zr Multilayered B2 98x18mm Disc |
| 00817340023268 | Imagine Zr Multilayered B1 98x18mm Disc |
| 00817340023251 | Imagine Zr Multilayered A3.5 98x18mm Disc |
| 00817340023244 | Imagine Zr Multilayered A4 98x18mm Disc |
| 00817340023237 | Imagine Zr Multilayered A3 98x18mm Disc |
| 00817340023220 | Imagine Zr Multilayered A2 98x18mm Disc |
| 00817340023213 | Imagine Zr Multilayered A1 98x18mm Disc |
| 00817340025101 | Imagine Enamel Liquid 15ml |
| 00817340025095 | Imagine X TRAN Zr A1 98x22 Disc |
| 00817340024579 | Imagine X TRAN Zr D4 98x14 Disc |
| 00817340024555 | Imagine X TRAN Zr D2 98x14 Disc |
| 00817340024548 | Imagine X TRAN Zr C4 98x14 Disc |
| 00817340024531 | Imagine X TRAN Zr C3 98x14 Disc |
| 00817340024524 | Imagine X TRAN Zr C2 98x14 Disc |
| 00817340024517 | Imagine X TRAN Zr C1 98x14 Disc |
| 00817340024500 | Imagine X TRAN Zr B4 98x14 Disc |
| 00817340024494 | Imagine X TRAN Zr B3 98x14 Disc |
| 00817340024487 | Imagine X TRAN Zr B2 98x14 Disc |
| 00817340024470 | Imagine X TRAN Zr B1 98x14 Disc |
| 00817340024463 | Imagine X TRAN Zr A4 98x14 Disc |
| 00817340024456 | Imagine X TRAN Zr A3.5 98x14 Disc |
| 00817340024449 | Imagine X TRAN Zr A3 98x14 Disc |
| 00817340024432 | Imagine X TRAN Zr A2 98x14 Disc |
| 00817340024425 | Imagine X TRAN Zr A1 98x14 Disc |
| 00817340025767 | Imagine Enamel Liquid 2 15ml |