DentalMonitoring - Candid

Primary DI
03760405340411
Brand
DentalMonitoring - Candid
Company
DENTAL MONITORING
Model
003
Catalog number
2001-001
Device description
Dental treatment remote monitoring
Published
2026-07-21
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
SBCDental Image Analyzer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SBCDental Image AnalyzerDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN230035000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN230035000DentalMonitoringDental Monitoring Sas2024-05-17SBC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760405340411PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760405340411037604053404113760405340411

GMDN Terms#

Term, Definition table
TermDefinition
Clinical decision management support softwareAn application software program intended to facilitate clinical management decisions by receiving patient data from electronic health records and/or manually-entered information (e.g., demographics, diagnostic/laboratory results) and returning clinical care information (e.g., reports, referral pathways, pedigree diagrams, reminders, post-therapy prognosis/risk score, anaesthesia/pharmaceutical dosage, guidelines links) to a healthcare professional responsible for patient care; it is not primarily intended to analyse or manage diagnostic/patient images. It may also be referred to as clinical decision support (CDS) software, and may be a locally-installed program, web-based, or mobile app.

Contacts#

Phone, Email table
PhoneEmail
1 737 300 6011support+dmus1@dentalmonitoring.com

Regulatory Flags#

DUNS number
269129881
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
true
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 From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760405340350DentalMonitoring0032001-0012026-07-21
03760405340404DentalMonitoring - Straumann0032001-0012026-07-21
03760405340428DentalMonitoring - Smile Doctors0032001-0012026-07-21
03760405340237DentalMonitoring - Smile Doctors0032001-0012025-06-06
03760405340244DentalMonitoring - Candid0032001-0012025-06-06
03760405340251DentalMonitoring - Straumann0032001-0012025-06-06
03770021392114DentalMonitoring0032001-0012024-12-02
03760405340282LED AdapterLED Adapter1016-0012025-12-17
03760405340121ScanBox pro Smile Doctors0011012-0012025-02-14
03760405340145ScanBox pro Smile doctors0011014-0012025-02-14
03760405340169ScanBox pro - Candid 0011015-0012025-02-14
03760405340206ScanBox pro 0011014-0012025-02-14
03760405340138ScanBox pro Smile Doctors0011012-0012025-02-14
03760405340152ScanBox pro Smile doctors0011014-0012025-02-14
03760405340176ScanBox pro - Candid 0011015-0012025-02-14
03760405340213ScanBox pro 0011014-0012025-02-14
03770021392824ScanBox pro 0011012-0012024-09-16
03770021392879ScanBox pro - Smile Doctors0011009-0012024-09-16
03770021392886ScanBox pro - Smile Doctors0011010-0012024-09-16
03770021392794ScanBox pro0011009-0012024-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760405340350DentalMonitoringDENTAL MONITORINGSBC2026-07-21
03760405340404DentalMonitoring - StraumannDENTAL MONITORINGSBC2026-07-21
03760405340428DentalMonitoring - Smile DoctorsDENTAL MONITORINGSBC2026-07-21
03760405340237DentalMonitoring - Smile DoctorsDENTAL MONITORINGSBC2025-06-06
03760405340244DentalMonitoring - CandidDENTAL MONITORINGSBC2025-06-06
03760405340251DentalMonitoring - StraumannDENTAL MONITORINGSBC2025-06-06
03770021392114DentalMonitoringDENTAL MONITORINGSBC2024-12-02