SplashMax® 030897101

GUDID D8130308971010

SPLASH MX JMB YL TIP&RNG 11pc

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

• Primary Device ID: D8130308971010
• NIH Device Record Key: 4c81902d-9c1f-4d47-ab55-62712d04ab76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SplashMax®
• Version Model Number: 030897101
• Catalog Number: 030897101
• Company DUNS: 809857704
• Company Name: DEN-MAT HOLDINGS, LLC
• Device Count: 11
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D8130308971010 [Unit of Use]
HIBCC	D8130308971011 [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 [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