AccessGUDID - DEVICE: DTX Studio™ design (07332747126464)

GUDID

Device Identifier (DI) Information

Brand Name: DTX Studio™ design
Version or Model: 1.5
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 300160
Company Name: Nobel Biocare AB

Primary DI Number: 07332747126464
Issuing Agency: GS1
Commercial Distribution End Date: February 09, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 353939929 *Terms of Use

Device Description: DTX Studio design 1.5 for Windows 64-bit

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	No
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?
50484	CAD/CAM software	A software program intended to provide computer-aided design (CAD) or computer-aided manufacturing (CAM) functionality for the production of patient-specific custom-made devices (e.g., orthopaedic implants, dental devices, anatomical models), treatment planning, simulation, and/or robotic capabilities for device production (e.g., 3-D printing). It may include functionality to upload patient-specific images and to facilitate communication between healthcare professionals.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NHA	ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
NOF	System, optical impression, computer assisted design and manufacturing (cad/cam) of dental restorations

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K171466	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c1c74e14-f8cc-47a2-9229-973536fec274
Public Version Date: February 21, 2022
Public Version Number: 6
DI Record Publish Date: February 07, 2018