Splash® SPD1211

GUDID D813SPD12110

SPLASH CART REG SET HVY BRY

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: D813SPD12110
• NIH Device Record Key: 04025aaf-864f-432f-ac28-36dee2604860
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Splash®
• Version Model Number: SPD1211
• Catalog Number: SPD1211
• 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
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 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 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 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 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 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 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 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 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 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 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 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 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 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 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 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 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 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 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 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 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 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 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 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 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 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 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 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 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 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 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 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 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D813SPD12110 [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 [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