AccessGUDID - DEVICE: DD Scanbody 2.0 (EDDIDDNREST50S1)

GUDID

Device Identifier (DI) Information

Brand Name: DD Scanbody 2.0
Version or Model: NRE 50 Set
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DDNREST50S
Company Name: Dental Direkt GmbH

Primary DI Number: EDDIDDNREST50S1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 313214171 *Terms of Use

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

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NDP	Accessories, Implant, Dental, Endosseous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Interface: 5.0mm; Compatible with Nobel Biocare™ Replace Select® system

Device Record Status

Public Device Record Key: db74d8a9-4e89-4c95-9090-91c4418c8543
Public Version Date: February 06, 2025
Public Version Number: 2
DI Record Publish Date: November 03, 2023