Pulp Canal Sealer

GUDID 00889989074161

Powder Refill - Root Canal Sealer (Jar, 10.5g each)

ORMCO CORPORATION

Hygroscopic dental cement

• Primary Device ID: 00889989074161
• NIH Device Record Key: 0c2c95f3-09ee-4e46-bb9d-922c144478e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pulp Canal Sealer
• Version Model Number: 24874
• Company DUNS: 154614119
• Company Name: ORMCO CORPORATION
• Device Count: 4
• 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: 42 Gram
• Weight: 42 Gram
• Weight: 42 Gram
• Weight: 42 Gram
• Weight: 42 Gram
• Weight: 42 Gram
• Weight: 42 Gram
• Weight: 42 Gram
• Weight: 42 Gram
• Weight: 42 Gram
• Weight: 42 Gram
• Weight: 42 Gram
• Weight: 42 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	00889989074161 [Primary]
GS1	10889989073123 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152956

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 [Pulp Canal Sealer]

• 00889989074178: Root Canal Sealer (1 - Jar (10.5g), 1 - Bottle (4mL)
• 00889989074161: Powder Refill - Root Canal Sealer (Jar, 10.5g each)
• 00889989074154: Liquid Refill - Root Canal Sealer (Bottle, 4mL each)