VAKT PRIVATE LABEL

GUDID D8130562005300

VAKT ALIGNER UPPER

DEN-MAT HOLDINGS, LLC

Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use
Primary Device IDD8130562005300
NIH Device Record Key7b5347a3-de04-4522-8285-d3ef03d3c5a6
Commercial Distribution StatusIn Commercial Distribution
Brand NameVAKT PRIVATE LABEL
Version Model Number056200530
Company DUNS809857704
Company NameDEN-MAT HOLDINGS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD8130562005300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NXCAligner, Sequential

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-14
Device Publish Date2023-03-06

On-Brand Devices [VAKT PRIVATE LABEL]

D8130562005550VAKT RETAINER LOWER
D8130562005500VAKT RETAINER UPPER
D8130562005300VAKT ALIGNER UPPER
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