| Primary Device ID | D89637115HA0 |
| NIH Device Record Key | 119767a5-63fb-4e49-93dd-714f3caa6124 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | American Dental Implant Corporation |
| Version Model Number | 37115HA |
| Catalog Number | 37115HA |
| Company DUNS | 835556429 |
| Company Name | AMERICAN DENTAL IMPLANT CORPORATION |
| 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 | true |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Phone | 800-511-0661 |
| info@americandentalimplant.com | |
| Phone | 800-511-0661 |
| info@americandentalimplant.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D89637115HA0 [Primary] |
| DZE | Implant, Endosseous, Root-Form |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-08-31 |
| Device Publish Date | 2018-07-31 |
| D8963716HA0 | 3.7mm x 16mm Standard Diameter Internal Hex Dental Implant HA Surface |
| D8963713HA0 | 3.7mm x 13mm Standard Diameter Internal Hex Dental Implant HA Surface |
| D89637115HA0 | 3.7mm x 11.5mm Standard Diameter Internal Hex Dental Implant HA Surface |
| D8963710HA0 | 3.7mm x 10mm Standard Diameter Internal Hex Dental Implant HA Surface |
| D8963708RBM0 | 3.7mm x 08mm Standard Diameter Internal Hex Dental Implant RBM Surface |
| D8963708HA0 | 3.7mm x 08mm Standard Diameter Internal Hex Dental Implant HA Surface |