| Primary Device ID | D780S1T30040 |
| NIH Device Record Key | 09666dba-ae2f-4bf9-9639-6e82f40574ac |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 3.25 x 15mm Simpler One Threaded Dental Implant |
| Version Model Number | S1T3004 |
| Catalog Number | S1T 3004 |
| Company DUNS | 203213343 |
| Company Name | Simpler Implant Solutions 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 | 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 |
| Phone | 800-565-3559 |
| simpler@simplerimplants.com | |
| Phone | 800-565-3559 |
| simpler@simplerimplants.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D780S1T30040 [Primary] |
| DZE | Implant, Endosseous, Root-Form |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[D780S1T30040]
Radiation Sterilization
[D780S1T30040]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-10-24 |
| D780SIT50040 | 3.25 mm diameter x 15 mm length Simpler One surgery Threaded hydroxylapatite (HA) coated denta |
| D780S1T30040 | Grit Blased Acid Etched Simpler One Stage Threaded two piece dental implant. 3.25 mm diameter x |