| Primary Device ID | 00817340022209 |
| NIH Device Record Key | befdbb62-5a3d-4e74-837a-8368398b3e53 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | InSync Ceramic System |
| Version Model Number | InSync Basic Layering Kit |
| Catalog Number | ZR278 |
| 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 | 00817340022209 [Primary] |
| EIH | Powder, Porcelain |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-23 |
| 00817340023367 | InSync Universal Spray Glaze |
| 00817340023329 | MiYO Pink Gingival Finishing System Kit |
| 00817340023312 | MiYO Finishing System Kit |
| 00817340023121 | MiYo Finishing System Kit |
| 00817340023114 | InSync Peter Pizzi Layering Kit |
| 00817340022216 | InSync Advanced Layering Kit |
| 00817340022209 | InSync Basic Layering Kit |
| 00817340022193 | InSync FC Stain & Glaze Kit |
| 00817340023381 | MiYO Gingival Esthetic System Kit |
| 00817340023374 | MiYO Esthetic System Kit |
| 00817340025545 | InSync Glaze Paste Flour 4g |
| 00817340025781 | InSync Glaze / Stain Liquid 25ml |