Sealapex Xpress

GUDID 00889989074215

Root Canal Sealer - Dual Syringe Delivery System (2 - 10.5g syringes and mixing tips)

ORMCO CORPORATION

Hygroscopic dental cement

• Primary Device ID: 00889989074215
• NIH Device Record Key: 79ea36eb-7dea-487f-8696-3b11dbc536e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sealapex Xpress
• Version Model Number: 33639
• Company DUNS: 154614119
• Company Name: ORMCO CORPORATION
• Device Count: 2
• 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: 21 Gram
• Weight: 21 Gram
• Weight: 21 Gram
• Weight: 21 Gram
• Weight: 21 Gram
• Weight: 21 Gram
• Weight: 21 Gram
• Weight: 21 Gram
• Weight: 21 Gram
• Weight: 21 Gram
• Weight: 21 Gram
• Weight: 21 Gram
• Weight: 21 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	00889989074215 [Primary]
GS1	10889989073062 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152959

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

Devices Manufactured by ORMCO CORPORATION

• 00889989073140 - Tubli-Seal: 2026-02-11 Root Canal Sealer 1 Tube each - Catalyst (5g) and Base (15g)
• 00889989073157 - Tubli-Seal: 2026-02-11 Root Canal Sealer - BULK PK24 ( Catalyst (5g) and Base (15g) each)
• 00889989074116 - Sealapex: 2026-02-11 Root Canal Sealer (1 Tube each - Catalyst (18g) and Base (12g))
• 00889989074123 - Sealapex: 2026-02-11 Root Canal Sealer - Bulk Package (24 Tubes each - Catalyst (18g) and Base (12g)
• 00889989074130 - Pulp Canal Sealer EWT: 2026-02-11 Powder Refill - Root Canal Sealer - Extended Work Time (Jar, 10.5g each)
• 00889989074147 - Pulp Canal Sealer EWT: 2026-02-11 Root Canal Sealer - Extended Work Time (1 - Jar (10.5g), 1 - Bottle (4mL))
• 00889989074154 - Pulp Canal Sealer: 2026-02-11 Liquid Refill - Root Canal Sealer (Bottle, 4mL each)
• 00889989074161 - Pulp Canal Sealer: 2026-02-11 Powder Refill - Root Canal Sealer (Jar, 10.5g each)