| Primary Device ID | D7854CATA50 |
| NIH Device Record Key | 3bba6c86-f7d1-4e06-9f72-430750104e5a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TSI/ERI/macro Custom Abutment |
| Version Model Number | TSI/ERI Transmucosal Abutment 5mm |
| Catalog Number | 4.0 CA |
| Company DUNS | 094146123 |
| Company Name | OCO BIOMEDICAL INC |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D7854CATA50 [Primary] |
| NHA | Abutment, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D7854CATA50]
Moist Heat or Steam Sterilization
[D7854CATA50]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-04-08 |
| D7856TSICAHC0 | TSI/ERI Transmucosal Healing Abutment 6mm 6mm Diameter |
| D785600940 | 6mm Bio-Torq Octagon Tip 6mm Diameter |
| D7855TSICAHC0 | TSI/ERI Transmucosal Healing Abutment 5mm 5mm Diameter |
| D7855IPUCLATSI60 | TSI/ERI UCLA Impression Pickup 6mm 6mm Diameter |
| D7855IPUCLATSI0 | TSI/ERI UCLA Impression Pickup 5mm 5mm Diameter |
| D785500940 | 5mm Bio-Torq Octagon Tip 5mm Diameter |
| D7854TSICAHC0 | TSI/ERI Transmucosal Healing Abutment 4mm 4mm Diameter |
| D7854IPUCLATSI0 | TSI/ERI UCLA Impression Pickup 4mm 4mm Diameter |
| D7854CATA60 | TSI/ERI Transmucosal Abutment 6mm 6mm Diameter |
| D7854CATA50 | TSI/ERI Transmucosal Abutment 5mm 5mm Diameter |
| D7854CATA0 | Transmucosal Abutment 4mm 4mm Diameter |
| D785400940 | 4mm Bio-Torq Octagon Tip 4mm Diameter |
| D785325TSICAHC0 | TSI/ERI Transmucosal Healing Abutment 3.25mm 3.25mm Diameter |
| D785325IPUCLATSI0 | TSI/ERI UCLA Impression Pickup 3.25mm 3.25mm Diameter |
| D785325CATA0 | TSI/ERI Transmucosal Abutment 3.25mm 3.25mm Diameter |
| D78532500840 | 3.25mm Bio-Torq Octagon Tip 3.25mm Diameter |