| Primary Device ID | D8199015000 |
| NIH Device Record Key | b079fa65-3c9f-4a5e-90c5-fb18bc013362 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 9mm Mini Screw Button Type |
| Version Model Number | 901500 |
| Company DUNS | 106645484 |
| Company Name | SPECIALTY APPLIANCES, 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 | false |
| 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 | D8199015000 [Primary] |
| OAT | Implant, Endosseous, Orthodontic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D8199015000]
Moist Heat or Steam Sterilization
[D8199015000]
Moist Heat or Steam Sterilization
[D8199015000]
Moist Heat or Steam Sterilization
[D8199015000]
Moist Heat or Steam Sterilization
[D8199015000]
Moist Heat or Steam Sterilization
[D8199015000]
Moist Heat or Steam Sterilization
[D8199015000]
Moist Heat or Steam Sterilization
[D8199015000]
Moist Heat or Steam Sterilization
[D8199015000]
Moist Heat or Steam Sterilization
[D8199015000]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-27 |
| Device Publish Date | 2024-11-19 |