FDA.reportPublic FDA data

DentalMonitoring

Primary DI
03770021392114
Brand
DentalMonitoring
Company
DENTAL MONITORING
Model
003
Catalog number
2001-001
Device description
Dental treatment remote monitoring
Published
2024-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
03770021392114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03770021392114037700213921143770021392114

GMDN Terms#

Term, Definition table
TermDefinition
Patient self-taken medical image communication softwareAn application software program intended to facilitate diagnosis/monitoring of a patient at home (e.g., between healthcare facility visits) by allowing self-taken patient images (i.e., taken by the patient in the home) to be sent to a clinician for review.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
269129881
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760405340282LED AdapterLED Adapter1016-0012025-12-17
03760405340237DentalMonitoring - Smile Doctors 0032001-0012025-06-06
03760405340244DentalMonitoring - Candid 0032001-0012025-06-06
03760405340251DentalMonitoring - Straumann 0032001-0012025-06-06
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
03770021392800ScanBox pro 0011010-0012024-09-16
03770021392916ScanBox pro - Candid0011011-0012024-09-16
03770021392831ScanBox pro0011009-0012024-09-16
03770021392848ScanBox pro 0011010-0012024-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760405340237DentalMonitoring - Smile Doctors DENTAL MONITORINGSBC2025-06-06
03760405340244DentalMonitoring - Candid DENTAL MONITORINGSBC2025-06-06
03760405340251DentalMonitoring - Straumann DENTAL MONITORINGSBC2025-06-06