ADSEAL

Basic Information

• Brand Name: ADSEAL
• Primary DI: 08806387892069
• Version / Model: 9206
• Company Name: Meta Biomed Co., Ltd.
• Labeler DUNS: 688322841
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 3
• Public Version Date: 2023-04-19
• Public Version Status: Update
• Public Device Record Key: 13de2de7-153e-4b0e-afdf-47eadb7538b7

Device Description

Adseal root canal sealer is a two component paste:paste device based upon epoxy-amine resin chemistry. This sealer is easy to mix and adapts closely to the walls of the prepared root canal and provides outstanding long-term dimensional stability with minimal shrinkage upon setting.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KIF	Resin, Root Canal Filling	Dental	872.3820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66609	Dental epoxy resin	A substance intended for professional use as a dental root canal sealant that consists of a chemical-curing epoxy resin material(s); it does not include any additional hardening fillers/components (i.e., not a composite resin). It may be provided as a powder and/or paste intended to be mixed prior to application; dedicated disposable devices associated with application may be included with the resin. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08806387892069	GS1