FDA.report

Velmeni for Dentists

Primary DI
00860010893203
Brand
Velmeni for Dentists
Company
Velmeni Inc.
Model
1.0
Catalog number
V4D
Published
2024-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
MYNAnalyzer, Medical Image

Product Code Classifications

CodeDeviceSpecialtyClass
MYNAnalyzer, Medical ImageRadiology2

Premarket Submissions

SubmissionSupplement
K240003000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K240003000Velmeni for Dentists (V4D)Velmeni, Inc.2024-08-30MYN

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00860010893203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010893203008600108932038600108932030860010893203

GMDN Terms

TermDefinition
Dental x-ray image interpretive softwareAn 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
119388763
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08801643467098NASamsung Electronics Co., Ltd.MYN2026-03-17
00860010268063DiagnocatDGNCT LLCMYN2026-01-29
07332747221855DTX Studio™ AssistNobel Biocare ABMYN2025-12-01
07332747221862DTX Studio™ AssistNobel Biocare ABMYN2025-12-01
00198715016079Second OpinionPearl Inc.MYN2025-07-31
M722X25122C250640ClearRead Xray DetectRiverain Technologies, Inc.MYN2025-06-17
M722XC25114C250640ClearRead Xray DetectRiverain Technologies, Inc.MYN2025-06-17
M722XD25114C250640ClearRead Xray DetectRiverain Technologies, Inc.MYN2025-06-17
08908023670038DeepTek CXR AnalyzerDEEPTEK MEDICAL IMAGING PRIVATE LIMITEDMYN2025-04-24
03770020839092ChestView USGLEAMERMYN2025-04-02
M722X25064C250640ClearRead Xray DetectRiverain Technologies, Inc.MYN2025-03-27
M722XC25064C250640ClearRead Xray DetectRiverain Technologies, Inc.MYN2025-03-27
M722XD25064C250640ClearRead Xray DetectRiverain Technologies, Inc.MYN2025-03-27
00860003567920Second OpinionPearl Inc.MYN2025-01-10
00860005586318Overjet Caries AssistOverjet, Inc.MYN2024-11-12
00860005586325Overjet Calculus AssistOverjet, Inc.MYN2024-11-12
00860005586332Overjet Periapical Radiolucency AssistOverjet, Inc.MYN2024-11-12
00860005586363Overjet Caries Assist-PediatricOverjet, Inc.MYN2024-11-12
B630QVCS346QVCAD SystemQVIEW MEDICALMYN2024-06-26
B630QVCSIK1202346QVCAD System Installation KitQVIEW MEDICALMYN2024-06-26
00850057636024qXR-LNQURE.AI TECHNOLOGIES PRIVATE LIMITEDMYN2024-06-24
07332747215212DTX Studio™ ClinicNobel Biocare ABMYN2024-04-17
M722XD24079C212210ClearRead Xray | DetectRiverain Technologies, Inc.MYN2024-04-15
00860009836822Videa Dental AssistVideahealth, Inc.MYN2024-01-15
07332747207422DTX Studio™ AI SDKNobel Biocare ABMYN2023-09-28
00852491008030Aorta-CADImagen Technologies, Inc.MYN2023-04-06
00860009836808Videa Caries AssistVideahealth, Inc.MYN2023-01-23
B630QVCS344QVCAD SystemQVIEW MEDICALMYN2022-10-06
B630QVCSIK1010344QVCAD System Installation KitQVIEW MEDICALMYN2022-10-06
00196852162192Videa Caries AssistVideahealth, Inc.MYN2022-07-06