Splash® SPD1183

GUDID D813SPD11830

SP MIX TIP TEAL 50PK

DEN-MAT HOLDINGS, LLC

Silicone dental impression material

• Primary Device ID: D813SPD11830
• NIH Device Record Key: 6bf3d610-a126-47be-8d94-16f56cdc68ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Splash®
• Version Model Number: SPD1183
• Catalog Number: SPD1183
• Company DUNS: 809857704
• Company Name: DEN-MAT HOLDINGS, LLC
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D813SPD11830 [Unit of Use]
HIBCC	D813SPD11831 [Primary]

FDA Product Code

• ELW: Material, Impression

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-30
• Device Publish Date: 2022-09-22

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