ScanBox pro - Smile Doctors

Basic Information

• Brand Name: ScanBox pro - Smile Doctors
• Primary DI: 03770021392886
• Version / Model: 001
• Catalog Number: 1010-001
• Company Name: DENTAL MONITORING
• Labeler DUNS: 269129881
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-16
• Public Version: 2
• Public Version Date: 2025-02-17
• Public Version Status: Update
• Public Device Record Key: b2daae6e-b815-4e63-b0d3-1e49996a9774
• Distribution End Date: 2025-02-14

Device Description

Phone support + Cheek retractor ScanBoxpro M-L Pack.The kit contains 3 elements: 2 Cheek Retractors: one Medium size (M) and oneLarge size (L). 1 Adapter 1 Phone support.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
EIG	Retractor, All Types	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44828	Dental cheek retractor, professional, reusable	A hands-free, self-retaining frame intended to allow a dental professional to retract the lips/cheeks of a patient during an orthodontic or restorative dental procedure for easy access to the field of operation. It is designed to be placed in and around the lips/cheeks and may also be designed to displace the tongue. It is a synthetic polymer device which may include suction adaptors/tubing for saliva removal to maintain a dry field. It is not intended to be placed between the teeth (i.e., not a mouth gag). This is a reusable device.	No	Active
63817	Dental cheek retractor, home-use	A hands-free, self-retaining frame intended to be used in the home by a patient to retract the lips/cheeks to facilitate viewing of the teeth (e.g., to allow photographs to be taken and sent to a healthcare professional). It is a synthetic polymer device designed to be placed in and around the lips/cheeks; it is not intended to be placed between the teeth (i.e., not a mouth gag). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	03770021392909	GS1	Shipping carton	12	Not in Commercial Distribution	2025-02-14
Primary	03770021392886	GS1
Direct Marking	03770021392022	GS1

Customer Contacts

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