Rotadent 94000WTYH

GUDID D81394000WTYH0

RD PROCARE WTY HANDLE

DEN-MAT HOLDINGS, LLC

Basic electric toothbrush

• Primary Device ID: D81394000WTYH0
• NIH Device Record Key: b843f5b6-565a-4eac-8615-79ebf7e66ea7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rotadent
• Version Model Number: 94000WTYH
• Catalog Number: 94000WTYH
• Company DUNS: 809857704
• Company Name: DEN-MAT HOLDINGS, LLC
• Device Count: 1
• 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: false
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D81394000WTYH0 [Primary]

FDA Product Code

• JEQ: Toothbrush, Powered

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: 2025-02-27
• Device Publish Date: 2025-02-19

Devices Manufactured by DEN-MAT HOLDINGS, LLC

• D81394000WTYH0 - Rotadent: 2025-02-27RD PROCARE WTY HANDLE
• D81394000WTYH0 - Rotadent: 2025-02-27 RD PROCARE WTY HANDLE
• 03598833235166 - EVANESCE: 2025-01-07 EVANESCE INJECTABLE ENW SYR
• 03598833235265 - EVANESCE: 2025-01-07 EVANESCE EVANESCE INJECTABLE
• 03598833235272 - EVANESCE: 2025-01-07 EVANESCE INJECTABLE A2U SYR
• 03598833235289 - EVANESCE: 2025-01-07 EVANESCE INJECTABLE B1U SYR
• 03598833235296 - EVANESCE: 2025-01-07 EVANESCE INJECTABLE BL1U SYR
• 03598833235302 - EVANESCE: 2025-01-07 EVANESCE INJECTABLE A3U SYR
• 00359883973216 - EVANESCE: 2024-12-23 EVANESCE BULK CURE A2 SY 1x3g