MegaBite® SPD1370
GUDID D813SPD13700
MEGABITE CART SET MINT
DEN-MAT HOLDINGS, LLC
Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material| Primary Device ID | D813SPD13700 |
| NIH Device Record Key | 0a139cbd-4b1c-4090-ac92-f512f6a4007b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MegaBite® |
| Version Model Number | SPD1370 |
| Catalog Number | SPD1370 |
| 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 |
Customer Support Contacts
| 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 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D813SPD13700 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K030776
FDA Product Code
| ELW | Material, Impression |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
Devices Manufactured by DEN-MAT HOLDINGS, LLC
| 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 |
Trademark Results [MegaBite]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MEGABITE 90672046 not registered Live/Pending |
MEGABITE CORP. 2021-04-26 |
 MEGABITE 86357319 not registered Dead/Abandoned |
PARK, Dong-ha 2014-08-05 |
 MEGABITE 85824990 4391902 Live/Registered |
Water Control Inc. Of Minnesota 2013-01-16 |
 MEGABITE 78248660 2897193 Live/Registered |
DEN-MAT HOLDINGS, LLC 2003-05-12 |
 MEGABITE 76611894 3068837 Dead/Cancelled |
OTC INNOVATIONS, LLC. 2004-09-17 |
 MEGABITE 75491614 2281069 Dead/Cancelled |
P.E.A. Products, Inc. 1998-05-27 |
 MEGABITE 75452346 not registered Dead/Abandoned |
JOHNSON & JOHNSON 1998-03-18 |
 MEGABITE 75201247 not registered Dead/Abandoned |
NICHE, INC. 1996-11-20 |
 MEGABITE 75126096 2047982 Dead/Cancelled |
Wellco Enterprises, Inc. 1996-06-27 |
 MEGABITE 73803076 1575039 Dead/Cancelled |
FLOOD, TIMOTHY B. 1989-05-30 |
 MEGABITE 73756098 1556483 Dead/Cancelled |
MARTIN, MILO A. 1988-10-05 |
MEGABITE 73756098 1556483 Dead/Cancelled |
MARTIN, CHERYL L. 1988-10-05 |
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