Injectable Root Canal Bioceramic Sealer

Basic Information

• Brand Name: Injectable Root Canal Bioceramic Sealer
• Primary DI: 06976329180010
• Version / Model: NR SP-1
• Company Name: Enpunuo Biotechnology Co., Ltd
• Labeler DUNS: 715461879
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-21
• Public Version: 1
• Public Version Date: 2024-07-01
• Public Version Status: New
• Public Device Record Key: 95fbb5a9-0268-4032-9e6c-b862fdc237a8

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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
60510	Hygroscopic dental cement	A substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material, root canal sealer) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction of a hygroscopic inorganic compound(s) [e.g., calcium silicates, calcium aluminates, zinc sulfate, calcium sulfate] with water (hydration). It is intended to be either mixed with water prior to application or react with dentinal fluid in situ. After application, this device cannot be reused.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	16976329180017	GS1		50	In Commercial Distribution
Primary	06976329180010	GS1

Premarket Submissions

Submission Number	Supplement Number
K240304	000