OrangeCAD Med

Basic Information

• Brand Name: OrangeCAD Med
• Primary DI: 04262365195678
• Version / Model: BICE2402H
• Catalog Number: BICE2402H
• Company Name: OrangeCAD MED GmbH
• Labeler DUNS: 343793874
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-10-29
• Public Version: 1
• Public Version Date: 2025-11-06
• Public Version Status: New
• Public Device Record Key: 187b35dd-5f01-429e-98bb-87fe099fce60

Device Description

Laboratory implant

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
NDP	Accessories, Implant, Dental, Endosseous	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61640	Dental implant abutment analog, laboratory	A rod-like device intended to be used as a copy of a dental implant abutment, for a dental laboratory working model, to confirm the orientation/position of the final dental implant; it may be used during a scanning procedure (e.g., with a laboratory scanner). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04262365195678	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Compatible: Biomet3i® - Certain®