Geo 3D Analog

Basic Information

• Brand Name: Geo 3D Analog
• Primary DI: 08800028704681
• Version / Model: 3D-SURO
• Company Name: GEOMEDI INC.
• Labeler DUNS: 694173762
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-03
• Public Version: 1
• Public Version Date: 2025-07-11
• Public Version Status: New
• Public Device Record Key: 808fe9f6-83d8-4e5d-8655-9bddf5422906

Device Description

Geo 3D Analog is a structure that is connected to the impression coping after the impression body is removed from the oral cavity, and is inserted into the dental plaster model. It is used to accurately replicate the location and dimensions of the fixture placed in the oral cavity during prosthesis fabrication, acting as a substitute for the actual fixture.

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: MR Conditional
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

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
61642	Dental implant analog	A device intended to be used as a copy of a dental implant, for a dental laboratory working model, to duplicate the location and restorative platform orientation of the final dental implant; it is not intended for intraoral use. It is a rod-like device made of metal [e.g., titanium (Ti)]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800028704681	GS1