VAKT
GUDID D8130561006970
VAKT ALIGNER UPR & LWR
DEN-MAT HOLDINGS, LLC
Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner 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
| D813444000L0 - CCD BLUEWAVE LASER | 2023-10-18 CCD LASER WIRELESS LOANER |
| D8130561006970 - VAKT | 2023-04-26VAKT ALIGNER UPR & LWR |
| D8130561006970 - VAKT | 2023-04-26 VAKT ALIGNER UPR & LWR |
| D8130303761050 - GBLOCK | 2023-03-14 GBLOCK DESENSITIZER 5ml |
| D8130303761100 - GBLOCK | 2023-03-14 GBLOCK DESENSITIZER 10ml |
| D8130562005300 - VAKT PRIVATE LABEL | 2023-03-14 VAKT ALIGNER UPPER |
| D8130562005350 - ORTHOCLEAR - PL VAKT | 2023-03-14 VAKT ALIGNER LOWER |
| D8130562005500 - VAKT PRIVATE LABEL | 2023-03-14 VAKT RETAINER UPPER |
| D8130562005550 - VAKT PRIVATE LABEL | 2023-03-14 VAKT RETAINER LOWER |
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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