DentalMonitoring 2001-001

GUDID 03770021392114

Dental treatment remote monitoring

DENTAL MONITORING

Patient self-taken medical image communication software

• Primary Device ID: 03770021392114
• NIH Device Record Key: e5b3d720-122c-44ee-9750-334609fc199c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DentalMonitoring
• Version Model Number: 003
• Catalog Number: 2001-001
• Company DUNS: 269129881
• Company Name: DENTAL MONITORING
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1 737 300 6011
• Email: support+dmus1@dentalmonitoring.com
• Phone: 1 737 300 6011
• Email: support+dmus1@dentalmonitoring.com
• Phone: 1 737 300 6011
• Email: support+dmus1@dentalmonitoring.com
• Phone: 1 737 300 6011
• Email: support+dmus1@dentalmonitoring.com
• Phone: 1 737 300 6011
• Email: support+dmus1@dentalmonitoring.com
• Phone: 1 737 300 6011
• Email: support+dmus1@dentalmonitoring.com
• Phone: 1 737 300 6011
• Email: support+dmus1@dentalmonitoring.com
• Phone: 1 737 300 6011
• Email: support+dmus1@dentalmonitoring.com
• Phone: 1 737 300 6011
• Email: support+dmus1@dentalmonitoring.com
• Phone: 1 737 300 6011
• Email: support+dmus1@dentalmonitoring.com
• Phone: 1 737 300 6011
• Email: support+dmus1@dentalmonitoring.com
• Phone: 1 737 300 6011
• Email: support+dmus1@dentalmonitoring.com
• Phone: 1 737 300 6011
• Email: support+dmus1@dentalmonitoring.com
• Phone: 1 737 300 6011
• Email: support+dmus1@dentalmonitoring.com
• Phone: 1 737 300 6011
• Email: support+dmus1@dentalmonitoring.com
• Phone: 1 737 300 6011
• Email: support+dmus1@dentalmonitoring.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03770021392114 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN230035

FDA Product Code

• SBC: Dental Image Analyzer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-10
• Device Publish Date: 2024-12-02

Devices Manufactured by DENTAL MONITORING

• 03770021392114 - DentalMonitoring: 2024-12-10Dental treatment remote monitoring
• 03770021392114 - DentalMonitoring: 2024-12-10 Dental treatment remote monitoring
• 03770021392831 - ScanBox pro: 2024-09-24 Cheeck Retractor for photo acquisition. ScanBox pro S-M Pack -The kit contains 4 elements: 2 Cheek Retractors: one Small size (S
• 03770021392848 - ScanBox pro: 2024-09-24 Cheeck Retractor for photo acquisition. ScanBox pro M-L Pack -The kit contains 4 elements: 2 Cheek Retractors: one Medium size (
• 03770021392855 - ScanBox pro: 2024-09-24 Cheeck Retractor for photo acquisition. ScanBox pro M-L Pack (without boxabox, plastic bag only) -The kit contains 4 elements: 2
• 03770021392893 - ScanBox pro - Smile Doctors: 2024-09-24 Phone support + Cheek retractor ScanBox pro S-M Pack.The kit contains 4 elements: 2 Cheek Retractors: one Small size (S) and one
• 03770021392909 - ScanBox pro - Smile Doctors: 2024-09-24 Phone support + Cheek retractor ScanBoxpro M-L Pack.The kit contains 3 elements: 2 Cheek Retractors: one Medium size (M) and one
• 03770021392923 - ScanBox pro - Candid: 2024-09-24 Phone support + Cheek retractor ScanBoxpro L Pack. The kit contains 3 elements: -1 Cheek Retractor: Large size (L). -1 Adaptor -