AccessGUDID - DEVICE: Dentbird Crown (08809953520021)

GUDID

Device Identifier (DI) Information

Brand Name: Dentbird Crown
Version or Model: V.4.X.X
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: IMAGOWORKS Inc.

Primary DI Number: 08809953520021
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 963215271 *Terms of Use

Device Description: Dentbird Crown is a software intended to support dental prostheses(crowns, bridges, in/onlays) design using 3D data from a patient's oral scan image. It receives oral scan data as input and recommends the tooth number, margin line, and initial values for dental prostheses(crowns, bridges, in/onlays) design using deep learning models and CAD algorithms. Additionally, users can directly modify the suggested design. The software can accept and export 3D intraoral scan data in a universal file format (.stl, .ply, .obj).

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?
38597	Dental milling system, CAD/CAM, chairside	An assembly of devices designed for automated computer-aided design (CAD) and computer-aided manufacturing (CAM) of custom-made (prescribed for one patient) dental restorations produced chairside during dental or orthodontic treatment. It typically includes, or is used in conjunction with, three-dimensional (3-D) image acquisition and viewing capabilities that provide values (measurements) for the production phase; software for record collection, treatment planning, simulation and device production; and robotic capabilities for the production of the actual devices to be fitted to the patient.	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: 2fdc0148-918a-4b27-9a0f-ad236cc835bb
Public Version Date: October 07, 2024
Public Version Number: 1
DI Record Publish Date: September 29, 2024