FDA.reportPublic FDA data

DentalMonitoring - Smile Doctors

Primary DI
03760405340237
Brand
DentalMonitoring - Smile Doctors
Company
DENTAL MONITORING
Model
003
Catalog number
2001-001
Device description
Dental treatment remote monitoring
Published
2025-06-06
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

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
03760405340237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760405340237037604053402373760405340237

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.

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
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 From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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
03760405340244DentalMonitoring - CandidDENTAL MONITORINGSBC2025-06-06
03760405340251DentalMonitoring - StraumannDENTAL MONITORINGSBC2025-06-06
03770021392114DentalMonitoringDENTAL MONITORINGSBC2024-12-02