VAKT
GUDID D8130561006970
VAKT ALIGNER UPR & LWR
DEN-MAT HOLDINGS, LLC
Orthodontic progressive aligner| Primary Device ID | D8130561006970 |
| NIH Device Record Key | d9fa9f6a-f10d-460c-9ff7-16a2a8bc694a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VAKT |
| Version Model Number | 056100697 |
| Company DUNS | 809857704 |
| Company Name | DEN-MAT HOLDINGS, 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 | true |
| Device Combination Product | false |
| Single Use | false |
| 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 |
Customer Support Contacts
| Phone | 1-914-768-8258 |
| info@vaktdirect.com | |
| Phone | 1-914-768-8258 |
| info@vaktdirect.com | |
| Phone | 1-914-768-8258 |
| info@vaktdirect.com | |
| Phone | 1-914-768-8258 |
| info@vaktdirect.com | |
| Phone | 1-914-768-8258 |
| info@vaktdirect.com | |
| Phone | 1-914-768-8258 |
| info@vaktdirect.com | |
| Phone | 1-914-768-8258 |
| info@vaktdirect.com | |
| Phone | 1-914-768-8258 |
| info@vaktdirect.com | |
| Phone | 1-914-768-8258 |
| info@vaktdirect.com | |
| Phone | 1-914-768-8258 |
| info@vaktdirect.com | |
| Phone | 1-914-768-8258 |
| info@vaktdirect.com | |
| Phone | 1-914-768-8258 |
| info@vaktdirect.com | |
| Phone | 1-914-768-8258 |
| info@vaktdirect.com | |
| Phone | 1-914-768-8258 |
| info@vaktdirect.com | |
| Phone | 1-914-768-8258 |
| info@vaktdirect.com | |
| Phone | 1-914-768-8258 |
| info@vaktdirect.com | |
| Phone | 1-914-768-8258 |
| info@vaktdirect.com | |
| Phone | 1-914-768-8258 |
| info@vaktdirect.com | |
| Phone | 1-914-768-8258 |
| info@vaktdirect.com | |
| Phone | 1-914-768-8258 |
| info@vaktdirect.com | |
| Phone | 1-914-768-8258 |
| info@vaktdirect.com | |
| Phone | 1-914-768-8258 |
| info@vaktdirect.com | |
| Phone | 1-914-768-8258 |
| info@vaktdirect.com | |
| Phone | 1-914-768-8258 |
| info@vaktdirect.com | |
| Phone | 1-914-768-8258 |
| info@vaktdirect.com | |
| Phone | 1-914-768-8258 |
| info@vaktdirect.com | |
| Phone | 1-914-768-8258 |
| info@vaktdirect.com | |
| Phone | 1-914-768-8258 |
| info@vaktdirect.com | |
| Phone | 1-914-768-8258 |
| info@vaktdirect.com | |
| Phone | 1-914-768-8258 |
| info@vaktdirect.com | |
| Phone | 1-914-768-8258 |
| info@vaktdirect.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D8130561006970 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K192470
FDA Product Code
| NXC | Aligner, Sequential |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-26 |
| Device Publish Date | 2023-04-18 |
Devices Manufactured by DEN-MAT HOLDINGS, LLC
| 03598833235166 - EVANESCE | 2025-01-07 EVANESCE INJECTABLE ENW SYR |
| 03598833235265 - EVANESCE | 2025-01-07 EVANESCE EVANESCE INJECTABLE |
| 03598833235272 - EVANESCE | 2025-01-07 EVANESCE INJECTABLE A2U SYR |
| 03598833235289 - EVANESCE | 2025-01-07 EVANESCE INJECTABLE B1U SYR |
| 03598833235296 - EVANESCE | 2025-01-07 EVANESCE INJECTABLE BL1U SYR |
| 03598833235302 - EVANESCE | 2025-01-07 EVANESCE INJECTABLE A3U SYR |
| 00359883973216 - EVANESCE | 2024-12-23 EVANESCE BULK CURE A2 SY 1x3g |
| 03598833215236 - EVANESCE | 2024-12-23 EVANESCE BULK FILL A2 SY 1X6G |
Trademark Results [VAKT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VAKT 79261107 5940907 Live/Registered |
VAKT Global Limited 2019-04-12 |
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