AccessGUDID - DEVICE: Videa Dental Assist (00860009836822)

GUDID

Device Identifier (DI) Information

Brand Name: Videa Dental Assist
Version or Model: VDA01BPN
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Videahealth, Inc.

Primary DI Number: 00860009836822
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117170604 *Terms of Use

Device Description: Update: Now commercialized under the brand name 'Videa Dental AI'. Videa Dental AI is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize suspect dental finding, historical treatment and normal anatomy features. Videa Dental Assist is indicated for the review of bitewing, periapical, and panoramic radiographs acquired from patients aged 3 years or older.

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?
65472	Dental x-ray image interpretive software	An interpretive software program intended to be used to analyse dental x-ray images (e.g., panoramic and bitewing) to facilitate the localization and classification of teeth, detect abnormalities (e.g., caries, apical lesion), and identify past dental procedures (e.g., fillings, crowns, bridges, implants); it utilizes artificial intelligence (AI)/deep learning algorithms.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MYN	Analyzer, Medical Image

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K232384	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: 2a281813-a611-43db-8788-73c708a4b826
Public Version Date: March 18, 2024
Public Version Number: 2
DI Record Publish Date: January 15, 2024