Primary Device ID | D824SCCHAD0 |
NIH Device Record Key | 315e954e-6af2-4d9f-aaf8-33a115845e1f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | MULTI-UNIT SCREW, HEX |
Version Model Number | SCCHad |
Company DUNS | 080321629 |
Company Name | SURGIKOR, 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 | true |
Manufacturing Date | false |
Expiration Date | false |
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 | D824SCCHAD0 [Primary] |
NHA | Abutment, Implant, Dental, Endosseous |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-08-21 |
Device Publish Date | 2019-08-13 |
D824IRH45070 - Immediate Implant | 2024-09-24 Ø4.5mm x L7.0mm, Regular Connection, Hex Platform |
D824IWC70110 - Immediate Implant | 2022-07-28 Ø7.0mm x L11.5mm, Conical Connection, Wide Platform |
D824IWC70130 - Immediate Implant | 2022-07-28 Ø7.0mm x L13.0mm, Conical Connection, Wide Platform |
D824PIWC70112 - Immediate Implant Pack | 2022-07-27 Ø7.0mm x L11.5mm, Conical Connection, Wide Platform with Cover Screw & Mount |
D824PIWC70130 - Immediate Implant Pack | 2022-07-27 Ø7.0mm x L13.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
D824SK15017S0 - Titanium Base for Cad / Cam | 2020-08-04 Hex Connection, Regular Platform, Non Indexed |
D824SK15041S0 - Titanium Base for Cad / Cam | 2020-08-04 Conical Connection, Regular Platform, Non Indexed |
D824SK15042S0 - Titanium Base for Cad / Cam | 2020-08-04 Conical Connection, Wide Platform, Non Indexed |