Integra-Ti 260-145-258
GUDID 00813110020925
4.5 x 8.0mm Integra-Ti Implant - 2.5mm Well
BICON, LLC
Basket endosteal dental implant, two-piece| Primary Device ID | 00813110020925 |
| NIH Device Record Key | 1e4e7094-89de-432f-a883-0b0a68a11bc3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Integra-Ti |
| Version Model Number | 260-145-258 |
| Catalog Number | 260-145-258 |
| Company DUNS | 945015758 |
| Company Name | BICON, 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 | false |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 617-524-4443 |
| support@bicon.com | |
| Phone | 617-524-4443 |
| support@bicon.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813110020925 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K994037
FDA Product Code
| DZE | Implant, Endosseous, Root-Form |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-03-07 |
On-Brand Devices [Integra-Ti]
| 00813110027856 | 4.5 x 5.0mm Integra-Ti Implant - 3.0mm Well |
| 00813110027429 | 3.0 x 6.0mm Integra-Ti Implant - 2.0mm Well |
| 00813110021212 | 6.0 x 5.7mm Integra-Ti Implant - 3.0mm Well |
| 00813110021205 | 6.0 x 6.0mm Integra-Ti Implant - 3.0mm Well |
| 00813110021199 | 6.0 x 5.0mm Integra-Ti Implant - 3.0mm Well |
| 00813110021083 | 5.0 x 11mm Integra-Ti Implant - 3.0mm Well |
| 00813110021076 | 5.0 x 8.0mm Integra-Ti Implant - 3.0mm Well |
| 00813110021069 | 5.0 x 6.0mm Integra-Ti Implant - 3.0mm Well |
| 00813110021052 | 5.0 x 5.0mm Integra-Ti Implant - 3.0mm Well |
| 00813110020956 | 4.5 x 11mm Integra-Ti Implant - 3.0mm Well |
| 00813110020949 | 4.5 x 8.0mm Integra-Ti Implant - 3.0mm Well |
| 00813110020932 | 4.5 x 6.0mm Integra-Ti Implant - 3.0mm Well |
| 00813110020925 | 4.5 x 8.0mm Integra-Ti Implant - 2.5mm Well |
| 00813110020918 | 4.5 x 6.0mm Integra-Ti Implant - 2.5mm Well |
| 00813110020901 | 4.5 x 5.0mm Integra-Ti Implant - 2.5mm Well |
| 00813110020895 | 4.5 x 11mm Integra-Ti Implant - 2.5mm Well |
| 00813110020819 | 4.0 x 8.0mm Integra-Ti Implant - 2.5mm Well |
| 00813110020802 | 4.0 x 6.0mm Integra-Ti Implant - 2.5mm Well |
| 00813110020796 | 4.0 x 5.0mm Integra-Ti Implant - 2.5mm Well |
| 00813110020789 | 4.0 x 11mm Integra-Ti Implant - 2.5mm Well |
| 00813110020727 | 4.0 x 11mm Integra-Ti Implant - 2.0mm Well |
| 00813110020710 | 4.0 x 8.0mm Integra-Ti Implant - 2.0mm Well |
| 00813110020666 | 3.5 x 11mm Integra-Ti Implant - 2.0mm Well |
| 00813110020659 | 3.5 x 8.0mm Integra-Ti Implant - 2.0mm Well |
| 00813110020635 | 3.0 x 8.0mm Integra-Ti Implant - 2.0mm Well |
| 00813110029119 | 4.0 x 5.0mm Integra-Ti Implant - 2.0mm Well |
Trademark Results [Integra-Ti]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INTEGRA-TI 77131668 3347410 Dead/Cancelled |
BICON, LLC 2007-03-15 |
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