| Primary Device ID | 00865515000217 |
| NIH Device Record Key | 597109eb-140a-4edf-af46-79f589de1486 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AcceleDent |
| Version Model Number | Optima |
| Company DUNS | 806256967 |
| Company Name | ORTHOACCEL TECHNOLOGIES, 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 | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |
|---|---|
| GS1 | 00865515000217 [Primary] |
| OYH | Orthodontic Vibratory Accessory |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-06-16 |
| 00865515000217 | Accelerated Orthodontic Treatment |
| 00865515000200 | Accelerated Orthodontic Treatment |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ACCELEDENT 85175399 4181657 Live/Registered |
OrthoAccel Technologies, Inc 2010-11-12 |