Advance Dental Products

Basic Information

• Brand Name: Advance Dental Products
• Primary DI: 10850002458616
• Version / Model: 502600-28
• Company Name: The Atlanta Dental Supply Company
• Labeler DUNS: 033505389
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-10
• Public Version: 1
• Public Version Date: 2023-02-20
• Public Version Status: New
• Public Device Record Key: b84cefbc-3df6-472e-8c25-d1905fe0f0c9

Device Description

Advance Calcium Hydroxide Standard Kit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
60275	Endodontic temporary cement	A viscous material intended to be applied to a prepared root canal to maintain its relative sterility between procedures and to facilitate its healing. It is intended to be placed within the root canal temporarily and sealed with a temporary filling material to prevent repopulation of the canal by bacteria. It is typically a zinc or calcium cement-based material that includes an antimicrobial agent (e.g., pharmaceutical or pH), and sometimes an anti-inflammatory agent, available in a tube or syringe. 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	10850002458616	GS1

Premarket Submissions

Submission Number	Supplement Number
K963922	000