Primary Device ID | D780S150080 |
NIH Device Record Key | 618a4369-d365-4ada-a5c0-65630094ec3a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | 4.0mm x 15mm Simpler One Push in Implant HA |
Version Model Number | S1 5008 |
Catalog Number | S1 5008 |
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 Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D780S150080 [Primary] |
DZE | Implant, Endosseous, Root-Form |
Steralize Prior To Use | true |
Device Is Sterile | true |
[D780S150080]
Radiation Sterilization
[D780S150080]
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 |
D780060376 - 6 x 13mm Simpler Threaded Dental Implant | 2018-03-29 6mm x 13mm Simpler Threaded Grit Blasted Acid Etched coated dental implant |
D78030220 - 6 x 10mm Simpler Threaded Dental Implant | 2018-03-29 6mm x 10mm Simpler Threaded Grit Blasted Acid Etched coated dental implant |
D780S0S33100 - 3.0mm x 10mm Maxi\Mini Dental Implant | 2018-03-29 Simpler One Piece Dental implant Grit Blasted Acid Etched |
D780S0S5531 - Simpli MaxiMini HA Implants | 2018-03-29 Simpli Simpler O Ring hydroxylapatite (HA) coating One Piece dental implants |
D780S0S56080 - 6 x 8mm Simpli MaxiMini HA Coated Dental Implants | 2018-03-29 6 x 8 Simpli Maximini One Piece Hydroxylapatite (HA) coated dental implants |
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 |