Dalbo®-Z

Basic Information

• Brand Name: Dalbo®-Z
• Primary DI: 07640173091684
• Version / Model: 050273
• Catalog Number: 050273
• Company Name: Cendres+Métaux SA
• Labeler DUNS: 487506230
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2021-01-08
• Public Version: 1
• Public Version Date: 2021-01-18
• Public Version Status: New
• Public Device Record Key: d727f986-71e2-4e6f-86b9-80fb32d07622

Device Description

Dalbo®-Z Elastomeric ring

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EJX	Anchor, Preformed	Dental	872.3130	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46307	Dental anchor	A device made of austenitic alloys or alloys containing 75 percent or greater gold (Au) or metals of the platinum group, intended to be incorporated into a dental appliance, such as a denture, to help stabilize the appliance in the patient's mouth.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	07640239930636	GS1
Primary	07640173091684	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight