| Primary Device ID | 00855992007199 |
| NIH Device Record Key | 75eb26f6-33c1-4b7a-8558-13aa6d9bbc42 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IDS Insight Dental Implant System |
| Version Model Number | 460110 |
| Company DUNS | 080676194 |
| Company Name | TITAN IMPLANT SYSTEMS, LLC |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 866-982-1511 |
| heather@insightdentalsystems.com |
| Width | 4.6 Millimeter |
| Width | 4.6 Millimeter |
| Width | 4.6 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00855992007199 [Primary] |
| DZE | Implant, Endosseous, Root-Form |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-08-09 |
| 00855992007359 | 5.4x12mm Bone Level Screw-Retained Finished System |
| 00855992007342 | 5.4x10mm Bone Level Screw-Retained Finished System |
| 00855992007335 | 5.4x8mm Bone Level Screw-Retained Finished System |
| 00855992007328 | 4.6x12mm Bone Level Screw-Retained Finished System |
| 00855992007311 | 4.6x10mm Bone Level Screw-Retained Finished System |
| 00855992007304 | 4.6x8mm Bone Level Screw-Retained Finished System |
| 00855992007298 | 3.8x12mm Bone Level Screw-Retained Finished System |
| 00855992007281 | 3.8x10mm Bone Level Screw-Retained Finished System |
| 00855992007274 | 3.8x8mm Bone Level Screw-Retained Finished System |
| 00855992007267 | 3.5x12mm Bone Level Screw-Retained Finished System |
| 00855992007250 | 3.5x10mm Bone Level Screw-Retained Finished System |
| 00855992007243 | 3.5x8mm Bone Level Screw-Retained Finished System |
| 00855992007236 | 5.4x12mm Tissue Level Finished System |
| 00855992007229 | 5.4x10mm Tissue Level Finished System |
| 00855992007212 | 5.4x8mm Tissue Level Finished System |
| 00855992007205 | 4.6x12mm Tissue Level Finished System |
| 00855992007199 | 4.6x10mm Tissue Level Finished System |
| 00855992007182 | 4.6x8mm Tissue Level Finished System |
| 00855992007175 | 3.8x12mm Tissue Level Finished System |
| 00855992007168 | 3.8x10mm Tissue Level Finished System |
| 00855992007151 | 3.8x8mm Tissue Level Finished System |
| 00855992007144 | 3.5x12mm Tissue Level Finished System |
| 00855992007137 | 3.5x10mm Tissue Level Finished System |
| 00855992007120 | 3.5x8mm Tissue Level Finished System |
| 00855992007113 | 5.4x12mm Bone Level Finished System |
| 00855992007106 | 5.4x10mm Bone Level Finished System |
| 00855992007090 | 5.4x8mm Bone Level Finished System |
| 00855992007083 | 4.6x12mm Bone Level Finished System |
| 00855992007076 | 4.6x10mm Bone Level Finished System |
| 00855992007069 | 4.6x8mm Bone Level Finished System |
| 00855992007052 | 3.8x12mm Bone Level Finished System |
| 00855992007045 | 3.8x10mm Bone Level Finished System |
| 00855992007038 | 3.8x8mm Bone Level Finished System |
| 00855992007021 | 3.5x12mm Bone Level Finished System |
| 00855992007014 | 3.5x10mm Bone Level Finished System |
| 00855992007007 | 3.5x8mm Bone Level Finished System |