HybenX 103-2001
GUDID 00813110027337
HybenX OTD Syringe (2-Pack)
BICON, LLC
Root canal cleaning solution| Primary Device ID | 00813110027337 |
| NIH Device Record Key | c7b3a5eb-4435-4692-a1ea-9938aaf05523 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HybenX |
| Version Model Number | 103-2001 |
| Catalog Number | 103-2001 |
| Company DUNS | 945015758 |
| Company Name | BICON, LLC |
| Device Count | 2 |
| 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 | false |
| 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 |
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 | 00813110027337 [Primary] |
| GS1 | 00813110027825 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K123538
FDA Product Code
| KJJ | Cleanser, Root Canal |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-05-06 |
| Device Publish Date | 2016-11-01 |
Devices Manufactured by BICON, LLC
| 00813110027276 - Universal Abutment | 2024-10-29 Universal Abutment UA6 SP 0° - 3.0mm Tall Post |
| 00813110027283 - Universal Abutment | 2024-10-29 Universal Abutment UA6 SP 15° - 3.0mm Tall Post |
| 00813110029744 - Scan Post | 2024-10-29 2.0mm Titanium Scan Post (2) |
| 00813110029751 - Scan Post | 2024-10-29 2.5mm Titanium Scan Post (2) |
| 00813110029768 - Scan Post | 2024-10-29 3.0mm Titanium Scan Post (2) |
| 00813110029775 - Temporary Abutment | 2024-10-29 6.5 x 4.5mm Scannable Temporary Abutment - 3.0mm Tall Post |
| 00813110029669 - Temporary Abutment | 2024-08-13 4.0 x 6.5mm Scannable Temporary Abutment - 3.0mm Post |
| 00813110029676 - Temporary Abutment | 2024-08-13 4.0 x 4.5mm Scannable Temporary Abutment - 3.0mm Tall Post |
Trademark Results [HybenX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HYBENX 78583357 3230986 Live/Registered |
EPIEN MEDICAL, INC. 2005-03-09 |
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