Straumann

Basic Information

• Brand Name: Straumann
• Primary DI: 04251574865519
• Version / Model: 025.0085
• Catalog Number: 025.0085
• Company Name: MEDENTiKA GmbH
• Labeler DUNS: 537555497
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-08
• Public Version: 2
• Public Version Date: 2025-02-06
• Public Version Status: Update
• Public Device Record Key: 13db194b-947f-4b7e-a2cb-e905c8dde3d8

Device Description

Scanbody BASE

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: 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
61641	Dental implant abutment analog, intraoral-scanning, single-use	An intraoral device intended to be used as a temporary copy of a dental implant abutment for attachment to a final dental implant and/or implant abutment during a scanning procedure to confirm its orientation/position as part of a dental restoration; it may in addition be intended for laboratory scanning. It is typically made of a radiopaque material (e.g., barium sulfate) and may be used in conjunction with an intraoral x-ray sensor. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04251574865519	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			compatible with Neodent Mini Conical