Luna-Orea

Basic Information

• Brand Name: Luna-Orea
• Primary DI: D815OREA95100
• Version / Model: OREA9510
• Catalog Number: OREA9510
• Company Name: OPA DENTAL LLC
• Labeler DUNS: 053308044
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-11
• Public Version: 5
• Public Version Date: 2019-11-04
• Public Version Status: Update
• Public Device Record Key: 4728dfdc-fd6e-413e-838f-ee3967ecf090

Device Description

Luna Orea dental zirconia

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EIH	Powder, Porcelain	Dental	872.6660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16187	Dental appliance fabrication material, ceramic	A dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D815OREA95100	HIBCC