| Primary Device ID | D780S1S53150 |
| NIH Device Record Key | 7a6acf76-b7c2-41b8-afe9-4d1e382004c7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 3 x 15mm Simpli Simpler One Piece GBAE Dental Implant |
| Version Model Number | S1S 5315 |
| Catalog Number | S1S 5315 |
| 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 | 1-800-565-3559 |
| simpler@simplerimplants.com | |
| Phone | 1-800-565-3559 |
| simpler@simplerimplants.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D780S1S53150 [Primary] |
| DZE | Implant, Endosseous, Root-Form |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[D780S1S53150]
Radiation Sterilization
[D780S1S53150]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-11-06 |
| D780S1S53150 | 3 x 15mm Simpli Simpler One Piece Hydroxylapatite Coated (HA) Dental Implant for Crown and Bridg |
| D780S1S33150 | 3x15mm Simpli Simpler One Piece Grit Blasted Acid Etched Dental Implant for Crown and Bridge |