| Primary Device ID | 08435453900355 |
| NIH Device Record Key | 8368eb5d-1ae5-4eda-b90e-d7e61e56d9c7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CeraRoot Implant System |
| Version Model Number | 001.007 |
| Catalog Number | 001.007 |
| Company DUNS | 467001948 |
| Company Name | CERAROOT SL. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Phone | +18184504776 |
| usa@ceraroot.com | |
| Phone | +18184504776 |
| usa@ceraroot.com | |
| Phone | +18184504776 |
| usa@ceraroot.com | |
| Phone | +18184504776 |
| usa@ceraroot.com | |
| Phone | +18184504776 |
| usa@ceraroot.com | |
| Phone | +18184504776 |
| usa@ceraroot.com | |
| Phone | +18184504776 |
| usa@ceraroot.com | |
| Phone | +18184504776 |
| usa@ceraroot.com | |
| Phone | +18184504776 |
| usa@ceraroot.com | |
| Phone | +18184504776 |
| usa@ceraroot.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08435453900355 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08435453900355]
Moist Heat or Steam Sterilization
[08435453900355]
Moist Heat or Steam Sterilization
[08435453900355]
Moist Heat or Steam Sterilization
[08435453900355]
Moist Heat or Steam Sterilization
[08435453900355]
Moist Heat or Steam Sterilization
[08435453900355]
Moist Heat or Steam Sterilization
[08435453900355]
Moist Heat or Steam Sterilization
[08435453900355]
Moist Heat or Steam Sterilization
[08435453900355]
Moist Heat or Steam Sterilization
[08435453900355]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-09-23 |
| Device Publish Date | 2019-09-14 |
| 08435453900249 | Implant CeraRoot 12:14/4.1 Size L= 14mm Indicated for UPPER LATERAL INCISORS AND LOWER IN |
| 08435453900232 | Implant CeraRoot 12:12/4.1 Size L= 12mm Indicated for UPPER LATERAL INCISORS AND LOWER IN |
| 08435453900225 | Implant CeraRoot 12:10/4.1 Size L= 10mm Indicated for UPPER LATERAL INCISORS AND LOWER IN |
| 08435453900218 | Implant CeraRoot 34:14/4.1-4.8 Size L= 14mm Indicated for CANINES AND PREMOLARS LONG ABUT |
| 08435453900201 | Implant CeraRoot 34:12/4.1-4.8 Size L= 12mm Indicated for CANINES AND PREMOLARS LONG ABUT |
| 08435453900195 | Implant CeraRoot 34:10/4.1-4.8 Size L= 10mm Indicated for CANINES AND PREMOLARS LONG A |
| 08435453900188 | Implant CeraRoot 34:8/4.1-4.8 Size L= 8mm Indicated for CANINES AND PREMOLARS LONG ABUTM |
| 08435453900171 | Implant CeraRoot 34:14/4.1-4.8 Size L= 14mm Indicated for CANINES AND PREMOLARS SHORT ABU |
| 08435453900164 | Implant CeraRoot 34:12/4.1-4.8 Size L= 12mm Indicated for CANINES AND PREMOLARS SHORT ABU |
| 08435453900157 | Implant CeraRoot 34:10/4.1-4.8 Size L= 10mm Indicated for CANINES AND PREMOLARS SHORT ABU |
| 08435453900140 | Implant CeraRoot 34:8/4.1-4.8 Size L= 8mm Indicated for CANINES AND PREMOLARS SHORT ABUTM |
| 08435453900133 | Implant CeraRoot 14:14/3.5-4.8 Size L= 14mm Indicated for BICUSPIDS/PREMOLAR One-piece |
| 08435453900126 | Implant CeraRoot 14:12/3.5-4.8 Size L= 12mm Indicated for BICUSPIDS/PREMOLAR One-piece zi |
| 08435453900119 | Implant CeraRoot 14:10/3.5-4.8 Size L= 10mm Indicated for BICUSPIDS/PREMOLAR One-piece zi |
| 08435453900102 | Implant CeraRoot 14:08/3.5-4.8 Size L= 08mm Indicated for BICUSPIDS/PREMOLAR One-piece zi |
| 08435453900096 | Implant CeraRoot 21:14/4.1-4.8 Size L= 14mm Indicated for UPPER CENTRAL INCISORS AND CUSP |
| 08435453900089 | Implant CeraRoot 21:12/4.1-4.8 Size L= 12mm Indicated for UPPER CENTRAL INCISORS AND CUSP |
| 08435453900072 | Implant CeraRoot 21:10/4.1-4.8 Size L= 10mm Indicated for UPPER CENTRAL INCISORS AND CUSP |
| 08435453900065 | Implant CeraRoot 11:14/4.8-6 Size L= 14mm Indicated for WIDE CENTRAL INCISORS AND CUSPIDS |
| 08435453900058 | Implant CeraRoot 11:12/4.8-6 Size L= 12mm Indicated for WIDE CENTRAL INCISORS AND CUSPIDS |
| 08435453900041 | Implant CeraRoot 11:10/4.8-6 Size L= 10mm Indicated for WIDE CENTRAL INCISORS AND CUSPIDS |
| 08435453900034 | Implant CeraRoot 16:14/4.8-6.5 Size L= 14mm Indicated for MOLARS One-piece zirconia denta |
| 08435453900027 | Implant CeraRoot 16:12/4.8-6.5 Size L= 12mm Indicated for MOLARS One-piece zirconia denta |
| 08435453900010 | Implant CeraRoot 16:10/4.8-6.5 Size L= 10mm Indicated for MOLARS One-piece zirconia denta |
| 08435453900270 | Twist Drill 2.8mm cylindrical, with laser marks at 6-8-10-12-14-16mm. Made of Steel. |
| 08435453900645 | Steel Tweezers with ceramic tip, designed to facilitate grasping and manipulation of soft-tissue |
| 08435453900638 | CeraRoot Surgical Case (empty). It's used to store all the necessary instruments to perform the |
| 08435453900621 | CeraRoot® Torque Wrench adapter - steel (Thumbwheel with an inside connection of universa |
| 08435453900614 | CeraRoot Surgical Torque Wrench Kit 35N - steel (this package includes the Adapter/Thumbwhee |
| 08435453900607 | Nobel Biocare® Torque Wrench adapter - steel |
| 08435453900591 | Straumann® Torque Wrench adapter - steel |
| 08435453900577 | Transporter 34 - ceramic for the CeraRoot 34 implant |
| 08435453900560 | Transporter 21 - ceramic for the CeraRoot 21 implant |
| 08435453900553 | Transporter 12 - ceramic for the CeraRoot 12 implant |
| 08435453900546 | Transporter 11 - ceramic for the CeraRoot 11 implant |
| 08435453900539 | Transporter 16 Short - ceramic for the CeraRoot 16 implant |
| 08435453900522 | Transporter 16 Long - ceramic for the CeraRoot 16 implant |
| 08435453900515 | Impactor for implant CeraRoot 14. A metal hand-held manual surgical instrument designed to posit |
| 08435453900508 | Surgical Mallet. Both ends of the head are covered by Teflon caps that are autoclavable. Length |
| 08435453900492 | Transporter 34 - steel for the CeraRoot 34 implant |
| 08435453900485 | Transporter 21 - steel for the CeraRoot 21 implant |
| 08435453900478 | Transporter 12 - steel for the CeraRoot 12 implant |
| 08435453900461 | Transporter 11 - steel for the CeraRoot 11 implant |
| 08435453900454 | Transporter 16 Short - steel for the CeraRoot 16 implant |
| 08435453900447 | Transporter 16 Long - steel for the CeraRoot 16 implant |
| 08435453900430 | Countersink 14 - for the implants CeraRoot 14 and the CeraRoot 34 and 34L- orange and violet col |
| 08435453900423 | Countersink 21 - for the implant CeraRoot 21 - red color coded - ceramic |
| 08435453900416 | Countersink 11 - for the implant CeraRoot 11 - green color coded - ceramic |
| 08435453900409 | Countersink 16 - for the implant CeraRoot 16 - black color coded - ceramic |
| 08435453900393 | Countersink 14 - for the implants CeraRoot 14 and the CeraRoot 34 and 34L- orange and violet col |