Primary Device ID | D813SPD11040 |
NIH Device Record Key | 9968e120-c3e5-43c7-a2a7-faf09749c374 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Clear Bite™ |
Version Model Number | SPD1104 |
Catalog Number | SPD1104 |
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 | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D813SPD11040 [Primary] |
ELW | Material, Impression |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-24 |
D8130398114010 - TENURE | 2024-05-16 TENURE MPB SYSTEM BAG |
D8130398140000 - TENURE | 2024-05-16 TENURE 4G SAMPLE PACK |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CLEAR BITE 77002533 not registered Dead/Abandoned |
Remarkable Dental Products Inc. 2006-09-19 |