MegaBite® SPD1370
GUDID D813SPD13700
MEGABITE CART SET MINT
DEN-MAT HOLDINGS, LLC
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
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| 00359883002046 - Affinity™ Heavy Body RS 120ml 2-Pack | 2025-03-24 VPS Impression Material |
| 00359883006273 - Final Shine Cotton Polishing Wheel 50-Pack | 2025-03-21 Wheel, Polishing Agent |
| 00359883006501 - Clinician's Choice® G5 Sample Pack | 2025-03-21 Dental coating, tooth-desensitizing, professional |
| 00359883000608 - PowerMix™ Automatic Impression Material Dispenser | 2025-03-20 Two-component dental material applicator, electric |
| 00359883000615 - PowerMix™ Dynamic Mixing Tips | 2025-03-20 Dental material mixing nozzle, non-sterile |
| 00359883000882 - Dual-Force™ Sectional Matrix System Pre-Molar Rings Orange | 2025-03-20 Device to engage the matrices and separate teeth |
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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