| Primary Device ID | D780S1S36100 |
| NIH Device Record Key | b4cca5d9-867b-411a-9fb7-d1bed2bba1b0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 6 x 10mm Simpli Simpler One Piece GBAE Dental Implants |
| Version Model Number | S1S 3610 |
| Catalog Number | S1S 3610 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D780S1S36100 [Primary] |
| DZE | Implant, Endosseous, Root-Form |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[D780S1S36100]
Radiation Sterilization
[D780S1S36100]
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 |
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| D780S0S33100 - 3.0mm x 10mm Maxi\Mini Dental Implant | 2018-03-29 Simpler One Piece Dental implant Grit Blasted Acid Etched |
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| D780S150020 - 3.5 x 10 Simpler One Push in Implant HA | 2018-03-29 3.5mm Diameter x 10mm length Simpler One Surgery Two Piece Hydroxylapatite (HA) coated Push in implant |
| D780S150030 - 3.25 x 13 Simpler One Push in Implant HA | 2018-03-29 3.5mm Diameter x 13mm length Simpler One Surgery Two Piece Hydroxylapatite (HA) coated Push in implant |
| D780S150040 - 3.25mm x 15mm Simpler One Push in Implant HA | 2018-03-29 3.5mm Diameter x 13mm length Simpler One Surgery Two Piece Hydroxylapatite (HA) coated Push in implant |