AccessGUDID - DEVICE: Glidewell Restorative CT (D745701152CTS00010)

GUDID

Device Identifier (DI) Information

Brand Name: Glidewell Restorative CT
Version or Model: 70-1152-CTS0001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 70-1152-CTS0001
Company Name: Prismatik Dentalcraft, Inc

Primary DI Number: D745701152CTS00010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 022761689 *Terms of Use

Device Description: Glidewell Restorative CT Scanner

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):	No
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
NOF	System, optical impression, computer assisted design and manufacturing (cad/cam) of dental restorations

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: 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: 131b91a2-581a-473a-b763-a6016e883fe5
Public Version Date: August 22, 2023
Public Version Number: 3
DI Record Publish Date: November 26, 2021