AcceleDent
GUDID 00865515000200
Accelerated Orthodontic Treatment
ORTHOACCEL TECHNOLOGIES, INC.
Orthodontic vibrator| Primary Device ID | 00865515000200 |
| NIH Device Record Key | 06735a00-51e0-48c6-8903-a77844fd4ad6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AcceleDent |
| Version Model Number | Aura |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00865515000200 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K130643
FDA Product Code
| OYH | Orthodontic Vibratory Accessory |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-06 |
On-Brand Devices [AcceleDent]
| 00865515000217 | Accelerated Orthodontic Treatment |
| 00865515000200 | Accelerated Orthodontic Treatment |
Trademark Results [AcceleDent]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACCELEDENT 85175399 4181657 Live/Registered |
OrthoAccel Technologies, Inc 2010-11-12 |
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