Tubli-Seal

GUDID 00889989073157

Root Canal Sealer - BULK PK24 ( Catalyst (5g) and Base (15g) each)

ORMCO CORPORATION

Hygroscopic dental cement

• Primary Device ID: 00889989073157
• NIH Device Record Key: 6a090ed5-a645-42f4-9c30-71ae6a55ef4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tubli-Seal
• Version Model Number: 01081
• Company DUNS: 154614119
• Company Name: ORMCO CORPORATION
• Device Count: 24
• 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: +18005377123
• Email: EndoRotaryCustCare@kerrdental.com
• Phone: +18005377123
• Email: EndoRotaryCustCare@kerrdental.com
• Phone: +18005377123
• Email: EndoRotaryCustCare@kerrdental.com
• Phone: +18005377123
• Email: EndoRotaryCustCare@kerrdental.com
• Phone: +18005377123
• Email: EndoRotaryCustCare@kerrdental.com
• Phone: +18005377123
• Email: EndoRotaryCustCare@kerrdental.com
• Phone: +18005377123
• Email: EndoRotaryCustCare@kerrdental.com
• Phone: +18005377123
• Email: EndoRotaryCustCare@kerrdental.com
• Phone: +18005377123
• Email: EndoRotaryCustCare@kerrdental.com
• Phone: +18005377123
• Email: EndoRotaryCustCare@kerrdental.com
• Phone: +18005377123
• Email: EndoRotaryCustCare@kerrdental.com
• Phone: +18005377123
• Email: EndoRotaryCustCare@kerrdental.com
• Phone: +18005377123
• Email: EndoRotaryCustCare@kerrdental.com
• Phone: +18005377123
• Email: EndoRotaryCustCare@kerrdental.com

Device Dimensions

• Weight: 480 Gram
• Weight: 480 Gram
• Weight: 480 Gram
• Weight: 480 Gram
• Weight: 480 Gram
• Weight: 480 Gram
• Weight: 480 Gram
• Weight: 480 Gram
• Weight: 480 Gram
• Weight: 480 Gram
• Weight: 480 Gram
• Weight: 480 Gram
• Weight: 480 Gram

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient temperature.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889989073157 [Primary]
GS1	10889989073017 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153067

FDA Product Code

• KIF: RESIN, ROOT CANAL FILLING

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2026-02-11
• Device Publish Date: 2016-09-08

On-Brand Devices [Tubli-Seal]

• 00889989073157: Root Canal Sealer - BULK PK24 ( Catalyst (5g) and Base (15g) each)
• 00889989073140: Root Canal Sealer 1 Tube each - Catalyst (5g) and Base (15g)