FDA.reportPublic FDA data

Overjet Periapical Radiolucency Assist

Primary DI
00860005586332
Brand
Overjet Periapical Radiolucency Assist
Company
Overjet, Inc.
Model
v1
Published
2024-11-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MYNAnalyzer, Medical Image

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MYNAnalyzer, Medical ImageRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860005586332PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860005586332008600055863328600055863320860005586332

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
116916753
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860013927820Overjet Iris Intelligent Imaging Systemv12026-05-13
00860005586394Overjet CBCT Assistv12025-12-12
00860005586301Overjet Dental Assistv12024-11-12
00860005586318Overjet Caries Assistv12024-11-12
00860005586325Overjet Calculus Assistv12024-11-12
00860005586349Overjet DI Systemv12024-11-12
00860005586356Overjet Charting Assistv12024-11-12
00860005586363Overjet Caries Assist-Pediatricv12024-11-12
00860005586370Overjet Image Enhancement Assistv12024-11-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00852491008047ChestSuiteImagen Technologies, Inc.MYN2026-04-15
00860015071101SugarBotBENCH7 INC.MYN2026-04-08
07332747236620DTX Studio™ ClinicNobel Biocare ABMYN2026-03-27
07332747236637DTX Studio™ ClinicNobel Biocare ABMYN2026-03-27
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
07332747225501DTX Studio™ ClinicNobel Biocare ABMYN2025-10-06
07332747225518DTX Studio™ ClinicNobel Biocare ABMYN2025-10-06
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
07332747221183DTX Studio™ ClinicNobel Biocare ABMYN2025-04-24
07332747221190DTX Studio™ ClinicNobel Biocare ABMYN2025-04-24
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
07332747219616DTX Studio™ ClinicNobel Biocare ABMYN2025-01-26
07332747219623DTX Studio™ ClinicNobel Biocare ABMYN2025-01-26
00860003567920Second OpinionPearl Inc.MYN2025-01-10
00860010893203Velmeni for DentistsVelmeni Inc.MYN2024-12-11
00860005586318Overjet Caries AssistOverjet, Inc.MYN2024-11-12
00860005586325Overjet Calculus 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