DentalMonitoring - Smile Doctors

Basic Information

• Brand Name: DentalMonitoring - Smile Doctors
• Primary DI: 03760405340237
• Version / Model: 003
• Catalog Number: 2001-001
• Company Name: DENTAL MONITORING
• Labeler DUNS: 269129881
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-06
• Public Version: 1
• Public Version Date: 2025-06-16
• Public Version Status: New
• Public Device Record Key: c7da3801-5b93-497a-b8f0-1c88840b5e59

Device Description

Dental treatment remote monitoring

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
SBC	Dental Image Analyzer	Dental	872.1770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61087	Clinical management support software	An 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, and/or links to guidelines) to a healthcare professional responsible for patient care; it is not primarily intended to analyse or manage diagnostic/patient images. Also known as clinical decision support (CDS) software, it may be a locally-installed program, web-based, or mobile application.	No	Active
63979	Patient self-taken medical image communication software	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03760405340237	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
DEN230035	000