SplashMax® SPD1602
GUDID D813SPD16021
SPLASHMAX BLK PK REG HVY 20PK
DEN-MAT HOLDINGS, LLC
Silicone dental impression material| Primary Device ID | D813SPD16021 |
| NIH Device Record Key | 2ab97142-4c27-4ca9-977e-20f024a4cff5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SplashMax® |
| Version Model Number | SPD1602 |
| Catalog Number | SPD1602 |
| Company DUNS | 809857704 |
| Company Name | DEN-MAT HOLDINGS, LLC |
| Device Count | 20 |
| 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
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D813SPD16020 [Unit of Use] |
| HIBCC | D813SPD16021 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K052090
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 |
On-Brand Devices [SplashMax®]
| D813SPD16171 | SPLASHMAX CRT HT SET XLT 2PK |
| D813SPD16161 | SPLASHMAX CRT HT SET LT 2PK |
| D813SPD16151 | SPLASHMAX CRT HT SET MED 2PK |
| D813SPD16141 | SPLASHMAX CRT HT SET HVY 2PK |
| D813SPD16131 | SPLASHMAX CRT REG SET XLT 2PK |
| D813SPD16121 | SPLASHMAX CRT REG SET LT 2PK |
| D813SPD16111 | SPLASHMAX CRT REG SET MED 2PK |
| D813SPD16101 | SPLASHMAX CRT REG SET HVY 2PK |
| D813SPD16091 | SPLASHMAX BLK PK LT HT 8PK |
| D813SPD16081 | SPLASHMAX BLK PK LT REG 8PK |
| D813SPD16071 | SPLASHMAX BLK PK XLT HT 8PK |
| D813SPD16061 | SPLASHMAX BLK PK XLT REG 8PK |
| D813SPD16051 | SPLASHMAX BLK PK MED HT 20PK |
| D813SPD16041 | SPLASHMAX BLK PK MED REG 20PK |
| D813SPD16031 | SPLASHMAX BLK PK HVY HT 20PK |
| D813SPD16021 | SPLASHMAX BLK PK REG HVY 20PK |
| D813SPD16010 | SPLASHMAX JUMBO CRT RFL MED KT |
| D813SPD16000 | SPLASHMAX JUMBO CRT RFL HVY KT |
| D8130308971010 | SPLASH MX JMB YL TIP&RNG 11pc |
Trademark Results [SplashMax]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPLASHMAX 86398384 4770410 Live/Registered |
PLAYMAX SURFACING, INC. 2014-09-18 |
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