DD Scanbody 2.0

Basic Information

• Brand Name: DD Scanbody 2.0
• Primary DI: EDDIDDSSYST65S1
• Version / Model: SSY 65 Set
• Catalog Number: DDSSYST65S
• Company Name: Dental Direkt GmbH
• Labeler DUNS: 313214171
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-03
• Public Version: 2
• Public Version Date: 2024-02-20
• Public Version Status: Update
• Public Device Record Key: 79eaf0e8-e4e6-4ca6-8032-0da49987e9f2

Device Description

DD Solid Connect® CAD/CAM Abutments are used to support prosthetic restorations in combination with endosseous dental implants in the upper and/or lower jaw. The Dental Direkt Scanbodies are used for digital acquisition of the implant position relative to the residual dentition and soft tissue. The Dental Direkt Scanbodies are available for various implant systems, are intended for optical acquisition and are screwed into the implant as a placeholder for intraoral scans or into the laboratory analog in the dental model.

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
61641	Dental implant abutment analog, scanning	A non-sterile device intended to be used as temporary copy of a dental implant abutment in a patient to confirm the position of the final dental implant body during dental implant restorative procedures. It is used during a scanning procedure, typically performed with a digital intraoral sensor (e.g., via x-ray imaging). It consists of a rod-like device intended to be attached to a dental implant; it is typically made of a radiopaque material (e.g., barium sulfate). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EDDIDDSSYST65S1	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Interface: 6.5mm; Compatible with Straumann® Tissue Level system