ZenSeal Pro

GUDID 00195062152771

ZenSeal Pro Bioceramic Root Canal Sealer (1 Syringe 1.5 grams, 20 Tips)

Kerr Corporation

Hygroscopic dental cement

• Primary Device ID: 00195062152771
• NIH Device Record Key: aef4987e-8989-4656-9b01-d41299ee43c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZenSeal Pro
• Version Model Number: 825-9511
• Company DUNS: 199354556
• Company Name: Kerr Corporation
• 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: 1-800-537-7123
• Email: EndoRotaryCustCare@kerrdental.com
• Phone: 1-800-537-7123
• Email: EndoRotaryCustCare@kerrdental.com
• Phone: 1-800-537-7123
• Email: EndoRotaryCustCare@kerrdental.com
• Phone: 1-800-537-7123
• Email: EndoRotaryCustCare@kerrdental.com
• Phone: 1-800-537-7123
• Email: EndoRotaryCustCare@kerrdental.com
• Phone: 1-800-537-7123
• Email: EndoRotaryCustCare@kerrdental.com
• Phone: 1-800-537-7123
• Email: EndoRotaryCustCare@kerrdental.com
• Phone: 1-800-537-7123
• Email: EndoRotaryCustCare@kerrdental.com
• Phone: 1-800-537-7123
• Email: EndoRotaryCustCare@kerrdental.com
• Phone: 1-800-537-7123
• Email: EndoRotaryCustCare@kerrdental.com
• Phone: 1-800-537-7123
• Email: EndoRotaryCustCare@kerrdental.com
• Phone: 1-800-537-7123
• Email: EndoRotaryCustCare@kerrdental.com
• Phone: 1-800-537-7123
• Email: EndoRotaryCustCare@kerrdental.com
• Phone: 1-800-537-7123
• Email: EndoRotaryCustCare@kerrdental.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *59°F - 77°F
• Special Storage Condition, Specify: Between 0 and 0 *59°F - 77°F
• Special Storage Condition, Specify: Between 0 and 0 *59°F - 77°F
• Special Storage Condition, Specify: Between 0 and 0 *59°F - 77°F
• Special Storage Condition, Specify: Between 0 and 0 *59°F - 77°F
• Special Storage Condition, Specify: Between 0 and 0 *59°F - 77°F
• Special Storage Condition, Specify: Between 0 and 0 *59°F - 77°F
• Special Storage Condition, Specify: Between 0 and 0 *59°F - 77°F
• Special Storage Condition, Specify: Between 0 and 0 *59°F - 77°F
• Special Storage Condition, Specify: Between 0 and 0 *59°F - 77°F
• Special Storage Condition, Specify: Between 0 and 0 *59°F - 77°F
• Special Storage Condition, Specify: Between 0 and 0 *59°F - 77°F
• Special Storage Condition, Specify: Between 0 and 0 *59°F - 77°F

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195062152771 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252890

FDA Product Code

• KIF: Resin, Root Canal Filling

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: 2026-02-18
• Device Publish Date: 2026-02-10

Devices Manufactured by Kerr Corporation

• 00195062145247 - ZenFlex CM: 2026-02-27 .13/.06/25mm ZenFlex CM NiTi FILE REFILL PACK
• 00195062145254 - ZenFlex CM: 2026-02-27 .13/.06/31mm ZenFlex CM NiTi FILE REFILL PACK
• 00195062145261 - ZenFlex CM: 2026-02-27 .15/.06/21mm ZenFlex CM NiTi FILE REFILL PACK
• 00195062145278 - ZenFlex CM: 2026-02-27 .15/.06/25mm ZenFlex CM NiTi FILE REFILL PACK
• 00195062145285 - ZenFlex CM: 2026-02-27 .15/.06/31mm ZenFlex CM NiTi FILE REFILL PACK
• 00195062145292 - ZenFlex CM: 2026-02-27 .17/.06/21mm ZenFlex CM NiTi FILE REFILL PACK
• 00195062145308 - ZenFlex CM: 2026-02-27 .17/.06/25mm ZenFlex CM NiTi FILE REFILL PACK
• 00195062145315 - ZenFlex CM: 2026-02-27 .17/.06/31mm ZenFlex CM NiTi FILE REFILL PACK