ROOTT
GUDID 00810149980497
Dental Implant, ROOTT R, D 3.5 mm, L 10 mm.
TRATE LLC
Screw endosteal dental implant, two-piece| Primary Device ID | 00810149980497 |
| NIH Device Record Key | c1e78a13-9f38-4d14-a420-8d00721c16af |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ROOTT |
| Version Model Number | R3510 |
| Company DUNS | 129946338 |
| Company Name | TRATE LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810149980480 [Primary] |
| GS1 | 00810149980497 [Package] Contains: 00810149980480 Package: [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K220022
FDA Product Code
| DZE | Implant, Endosseous, Root-Form |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-06 |
| Device Publish Date | 2024-10-29 |
On-Brand Devices [ROOTT]
| 00810149980930 | Dental Implant, ROOTT R, D 3.5 mm, L 14 mm. |
| 00810149980497 | Dental Implant, ROOTT R, D 3.5 mm, L 10 mm. |
| 00810149980084 | Dental Implant, ROOTT R, D 3.5 mm, L 12 mm. |
| 00810149980015 | Dental Implant, ROOTT R, D 3.5 mm, L 8 mm. |
| 00810149980992 | Dental Implant, ROOTT R, D 4.8 mm, L 12 mm. |
| 00810149980978 | Dental Implant, ROOTT R, D 4.8 mm, L 10 mm. |
| 00810149980954 | Dental Implant, ROOTT R, D 4.2 mm, L 12 mm. |
| 00810149980633 | Dental Implant, ROOTT R, D 3.8 mm, L 12 mm. |
| 00810149980619 | Dental Implant, ROOTT R, D 5.5 mm, L 10 mm. |
| 00810149980596 | Dental Implant, ROOTT R, D 5.5 mm, L 8 mm. |
| 00810149980572 | Dental Implant, ROOTT R, D 4.8 mm, L 8 mm. |
| 00810149980558 | Dental Implant, ROOTT R, D 4.2 mm, L 14 mm. |
| 00810149980534 | Dental Implant, ROOTT R, D 4.2 mm, L 8 mm. |
| 00810149980510 | Dental Implant, ROOTT R, D 3.8 mm, L 14 mm. |
| 00810149980107 | Dental Implant, ROOTT R, D 3.8 mm, L 8 mm. |
| 00810149980060 | Dental Implant, ROOTT R, D 3.8 mm, L 10 mm. |
| 00810149980046 | Dental Implant, ROOTT R, D 4.2 mm, L 10 mm. |
| 00810149981395 | Abutment, 15°, 1 mm, R. |
| 00810149981456 | Abutment, 25°, 3 mm, R. |
| 00810149981432 | Abutment, 25°, 1 mm, R. |
| 00810149981388 | Abutment, 4 mm, R. |
| 00810149981340 | Healing abutment, narrow, 6 mm, R. |
| 00810149981326 | Healing abutment, narrow, 2 mm, R. |
| 00810149981449 | Abutment, 25°, 2 mm, R. |
| 00810149981357 | Abutment, 1 mm, R. |
| 00810149981418 | Abutment, 15°, 3 mm, R. |
| 00810149981296 | Healing abutment, 4 mm, R. |
| 00810149981272 | Healing abutment, 1 mm, R. |
| 00810149981425 | Abutment, 15°, 4 mm, R. |
| 00810149981463 | Abutment, 25°, 4 mm, R. |
| 00810149981333 | Healing abutment, narrow, 4 mm, R. |
| 00810149981319 | Healing abutment, 6 mm, R. |
| 00810149981371 | Abutment, 3 mm, R. |
| 00810149981364 | Abutment, 2 mm, R. |
| 00810149981401 | Abutment, 15°, 2 mm, R. |
| 00810149981289 | Healing abutment, 2 mm, R. |
| 00810149981302 | Healing abutment, 5 mm, R. |
Trademark Results [ROOTT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ROOTT 97832141 not registered Live/Pending |
Restoring Our Own Through Transformation 2023-03-10 |
 ROOTT 97832125 not registered Live/Pending |
Restoring Our Own Through Transformation 2023-03-10 |
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