Primary Device ID | D813031145201B0 |
NIH Device Record Key | b15f10df-696b-4e70-b380-eaaa97bfc1f5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Dab-Eze® |
Version Model Number | 031145201B |
Catalog Number | 031145201B |
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 | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
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 |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com |
Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D813031145201B0 [Primary] |
KLE | Agent, Tooth Bonding, Resin |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-24 |
D813444000L0 - CCD BLUEWAVE LASER | 2023-10-18 CCD LASER WIRELESS LOANER |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DAB-EZE 74194234 1701618 Dead/Cancelled |
DEN-MAT HOLDINGS, LLC 1991-08-13 |