| Primary Device ID | D985HE352000 |
| NIH Device Record Key | 57b258dc-a9af-4129-b2b0-a54e421bdc5d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NBB External Hex |
| Version Model Number | 3.5 Abutment Screw |
| Catalog Number | HE35200 |
| Company DUNS | 081135800 |
| Company Name | FUSION DENTAL IMPLANTS 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D985HE352000 [Primary] |
| NHA | Abutment, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D985HE352000]
Moist Heat or Steam Sterilization
[D985HE352000]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-05-30 |
| D985HE419060 | Lock-Attach Dental Implant Abutment |
| D985HE419050 | Lock-Attach Dental Implant Abutment |
| D985HE419040 | Lock-Attach Dental Implant Abutment |
| D985HE419030 | Lock-Attach Dental Implant Abutment |
| D985HE419020 | Lock-Attach Dental Implant Abutment |
| D985HE419010 | Lock-Attach Dental Implant Abutment |
| D985HE416100 | Provisional Dental Implant Abutment. non engaging |
| D985HE416000 | Provisional Dental Implant Abutment |
| D985HE415500 | Dental Implant abutment. non engaging |
| D985HE415020 | Dental Implant Abutment. Engaging, 10mm |
| D985HE415010 | Dental Implant Abutment. Engaging 7mm |
| D985HE415000 | Dental Implant abutment. engaging |
| D985HE359050 | Lock-Attach Dental Implant Abutment |
| D985HE359040 | Lock-Attach Dental Implant Abutment |
| D985HE359030 | Lock-Attach Dental Implant Abutment |
| D985HE359020 | Lock-Attach Dental Implant Abutment |
| D985HE359010 | Lock-Attach dental Implant Abutment |
| D985HE358030 | Multi-unit Dental Implant Abutment |
| D985HE358020 | Multi-unit Dental Implant Abutment |
| D985HE358010 | Multi-unit Dental Implant Abutment |
| D985HE356000 | Dental implant provisional abutment |
| D985HE355500 | Dental Implant abutment. non engaging |
| D985HE355000 | Dental Implant abutment. engaging |
| D985HE354050 | Healing Dental Implant Abutment |
| D985HE354030 | Healing Dental Implant Abutment |
| D985HE352000 | Dental Implant Abutment Screw |