SugarBot

Primary DI
00860015071101
Brand
SugarBot
Company
BENCH7 INC.
Model
1.1.0
Published
2026-04-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
MYNAnalyzer, Medical Image

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MYNAnalyzer, Medical ImageRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250264000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250264000SugarBug (1.x)Bench7, Inc.2025-11-07MYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860015071101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860015071101008600150711018600150711010860015071101

GMDN Terms#

Term, Definition table
TermDefinition
Dental clinical assessment support radiology softwareA software program intended to display, analyse/process, and possibly acquire images of the teeth/gums, and typically surrounding region, to support a healthcare provider with clinical assessment (e.g., diagnosis, triage) of a dental condition. The images are typically acquired via x-ray [e.g., cone beam computed tomography (CBCT)] or by an intraoral camera. It is not dedicated to surgical planning or navigation, and does not incorporate adaptive/dynamic machine learning (ML) models.

Regulatory Flags#

DUNS number
138396139
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04262352357935DS Core DetectZetta25 AGMYN2026-06-03
00852491008047ChestSuiteImagen Technologies, Inc.MYN2026-04-15
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
00860005586332Overjet Periapical Radiolucency AssistOverjet, Inc.MYN2024-11-12
00860005586363Overjet Caries Assist-PediatricOverjet, Inc.MYN2024-11-12
B630QVCS346QVCAD SystemQVIEW MEDICALMYN2024-06-26