Splash® SPD1559

GUDID D813SPD15590

SPLASH JUMBO CART REFILL HVY

DEN-MAT HOLDINGS, LLC

Silicone dental impression material

• Primary Device ID: D813SPD15590
• NIH Device Record Key: deeaf3d1-a452-4050-877f-718aeb0a7def
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Splash®
• Version Model Number: SPD1559
• Catalog Number: SPD1559
• 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: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: 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	D813SPD15590 [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: 2016-12-12

On-Brand Devices [Splash® ]

• D813SPD15941: SPLASH BULK PACK HT HVY BRY
• D813SPD15931: SPLASH BULK PACK HT MED BRY
• D813SPD15921: SPLASH 8PK HT LITE BRY
• D813SPD15911: SPLASH 8PK HT XLITE BRY
• D813SPD15901: SPLASH BLK PK REG HVY BRY
• D813SPD15891: SPLASH BLK PK REG MED BRY
• D813SPD15881: SPLASH 8PK REG LITE BRY
• D813SPD15871: SPLASH 8PK REG XLITE BRY
• D813SPD15600: SPLASH JUMBO CART REFILL MED
• D813SPD15590: SPLASH JUMBO CART REFILL HVY
• D813SPD15320: SPLASH FATPAK INTRO MED
• D813SPD15310: SPLASH FATPAK INTRO HVY
• D813SPD15300: SPLASH FATPAK REFILL MED
• D813SPD15290: SPLASH FATPAK REFILL HVY
• D813SPD13501: SPLASH PTY HT SET BLK BX 200pc
• D813SPD12501: SPLASH PTY PK REG SET BX 400pc
• D813SPD12371: SPLASH HT PTY PK BRY
• D813SPD12350: SPLASH HT JAR PTY BRY
• D813SPD12330: SPLASH CART HT SET HVY BRY
• D813SPD12320: SPLASH HT CART SET MED BRY
• D813SPD12310: SPLASH HT CART SET LITE BRY
• D813SPD12300: SPLASH HT CART SET XLITE BRY
• D813SPD12190: SPLASH PTY PAK REG SET BRY
• D813SPD12120: SPLASH PTY JAR REG SET BRY
• D813SPD12110: SPLASH CART REG SET HVY BRY
• D813SPD12100: SPLASH CART REG SET MED BRY
• D813SPD12090: SPLASH CART REG SET LITE BRY
• D813SPD12080: SPLASH CART REG SET XLITE BRY
• D813SPD19080: SPLASH XLITE REG CART 3pc
• D813SPD19070: SPLASH LITE REG CART 5pc
• D813SPD19060: SPLASH MEDIUM REG CART 5pc
• D813SPD19050: SPLASH HEAVY REG CART 5pc
• D813SPD19040: SPLASH XLITE HT CART 3pc
• D813SPD19030: SPLASH LITE HT CART 5pc
• D813SPD19020: SPLASH MEDIUM HT CART 5pc
• D813SPD19010: SPLASH HEAVY HT CART 5pc
• D813SPD19000: SPLASH MED HT 10pc w/12 MXTIPS
• D813SPD15280: FATPAK BAG OF TIPS SPLSH&PREC
• D813SPD13250: PF TMP MIX GOLD TIPS 25PK
• D813SPD11900: TIPS IO WHITE 50pc
• D813SPD11840: SP IO TIPS CLEAR 50PK
• D813SPD11830: SP MIX TIP TEAL 50PK
• D8132222851: SP 10 TIPS WHT 6PK
• D8131115100: TIP JUMBO CART SPLSH/PREC 25pc